Safety Profile and Adverse Events of High-Power Laser Systems: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract

Background:

With recent technological advances, high-power laser systems with maximum power output of 150 W have shown advantages over standard-power laser systems in urological procedures. Our study aims to utilize the Manufacturer and User Facility Device Experience (MAUDE) database to examine the real-world safety profile of high-power laser systems.

Methods:

We searched the MAUDE database for reports on high-power laser systems, including Holmium Yttrium-Aluminum-Garnet (YAG), Thulium fiber laser, and Thulium YAG, from 1993 to 2024. Complications were identified and categorized.

Results:

A total of 1294 reports were found on initial search, of which 273 reports pertaining to high-power laser systems met inclusion criteria. We found 205 reports involving Holmium YAG, with 138 reports for laser lithotripsy and 67 for laser enucleation of the prostate. Most Holmium YAG complications were Clavien Dindo grade I and II events (n = 170, 92.9%), with renal colic (n = 38) and fever (n = 34) being the most frequently reported. There were 68 reports involving Thulium fiber laser systems, 66 of which were for laser lithotripsy. These reports consisted of a high number of grade III and IV postoperative events (n = 24, 85.7%), with ureteral stricture being the most common complication (n = 17). Ten ureteral strictures took place between first clinical use in June 2020 and June 2021, while 6 occurred between July 2021 and October 2024. No Thulium YAG reports met inclusion criteria.

Conclusions:

Our analysis showed minor adverse events associated with high-power Holmium YAG laser systems, indicating an overall strong safety profile. We also found that Thulium fiber laser systems showed a high number of CD grade III and IV complications, particularly ureteral strictures, most of which occurred prior to June 2021. We suggest that urologists should appreciate the risks associated with the use of novel technologies and be thoughtful about technology uptake.

Keywords

complication laser surgery MAUDE prostate cancer

Introduction

The application of laser technology in urology serves two purposes: laser lithotripsy for the treatment of urolithiasis and ablation/enucleation of soft tissue in the urinary tract for the treatment of benign prostate hyperplasia and urinary tract malignancies. In general, laser surgeries have shown several advantages over traditional surgeries, including improved precision, lower invasiveness, and better outcomes for patients with comorbidities.¹

Recent technological advances have brought more attention to higher power and higher frequency laser systems in hopes of achieving faster ablation and increased cost-effectiveness. Specifically, soft tissue ablation and stone treatment both benefit from higher maximum power, while stone dusting improves with lower-pulse energy and higher frequency. These improvements can be seen across Holmium:Yttrium-Aluminum-Garnet (Ho:YAG), Thulium:Yttrium-Aluminum-Garnet (Tm:YAG), and Thulium fiber laser (TFL) systems. In this paper, HP lasers are defined primarily as laser generators that have the capabilities to reach 100 W or higher, as opposed to traditional, lower powered laser generators that typically max out at around 10 to 35 W.^2–4

Despite increased clinical application of these high-power (HP) laser generators, there exists a notable gap in the evaluation of the safety profile of these machines. In this study, we aim to conduct an in-depth analysis of the MAUDE database to investigate the safety profile of HP laser generators in endourological indications.

Methods

Data source

In this study, we utilized the Manufacturer and User Facility Device Experience (MAUDE) Database. The MAUDE database is a federal database that contains medical device reports of adverse events.⁵ Medical device manufacturers are required to submit reports to the MAUDE database if their device may have malfunctioned or caused or contributed to death or serious injury of patients. Device user facilities are required to report adverse events to MAUDE if medical devices are reasonably suspected to have caused such adverse events. These reports contain information such as device problem, patient problem, report date, and description of the event, as well as the manufacturer’s narrative for the event.

Database review

We searched the MAUDE database for reports on HP laser systems from 1993 to 2024. The database review was conducted manually by two authors (B.X., J.S.). Keywords including “Moses, Lumenis Moses Pulse 120H, Dornier Medilas 140, Quanta Litho 150, Cook Litho 150, Quanta Cyber Ho, Cook Cyber Ho” were used to search for Ho:YAG laser systems. Keywords including “Soltive, Soltive SuperPulsed Laser System, Coloplast TFL drive, EMS Laserclast Thulium, Quanta Fiberdust, Cook Fiberdust” were used to search for TFL systems. Keywords including “Dornier Thulio, Quanta Cyber^TM, Cook Cyber^TM” were used to search for Tm:YAG laser systems. Duplicated reports, reports of laser fibers, and reports with unknown or non-urological indications were excluded. Reports of events that did not impact the patient or result in cancelation or delay of the operation were also excluded.

Main outcome measures

The primary outcome measure was the identification and classification of adverse events and complications linked to HP laser systems. Each adverse event was categorized by indication, whether it occurred during the intraoperative or postoperative period, and type of injury. Postoperative complications were additionally characterized based on severity, which was determined by the Clavien-Dindo (CD) classification system. Since each report may include more than one complication, the CD grade of each report was assigned as the CD grade of the most severe complication reported. Frequency of indication and CD classification were calculated based on the total number of patients or reports. Frequency of each injury was calculated based on the total number of complications. Following the classification method described by Gupta et al.,⁶ we categorized the relationship between device malfunction and each intraoperative or postoperative complication into three groups: definitely related, possibly related, and not related. This classification was primarily based on the “Device Malfunction” field of each report, supplemented by narratives provided in the event description and manufacturer narrative. Reports labeled as “Adverse Event Without Identified Device or Use Problem” were classified as not related, while those with insufficient detail were classified as possibly related. All other reports with clear device malfunction-related issues were classified as definitely related. Initial review and classifications were performed by authors (B.X., J.S.), with adjudications performed by additional authors (Z.Q., B.T.). All classifications were finalized by senior author (D.A.W.).

Statistical analyses

We primarily utilized descriptive statistical analysis for the data retrieved from the MAUDE database. All statistical analyses were performed using Stata 17 (StataCorp LLC, College Station, TX, USA).

Results

Overview

A total of 1294 MAUDE reports were found using the keywords provided, and 273 reports met the inclusion criteria of our analysis. Of the included reports, 204 (74.7%) reports were for stone ablation procedures, while 69 (25.3%) reports were for soft tissue ablation (Tables 1 and 2). In addition, 205 (75.1%) involved Ho:YAG systems, 68 (24.9%) involved TFL systems, and no Tm:YAG systems met inclusion criteria.

Table 1.

Indication, CD Grades, and Relation to Device Malfunction of Postoperative Complications Associated with High-Power Laser Generators on the MAUDE Database

Device type	TFL (n, %)	Ho:YAG (n, %)	Total (n, %)
Total number of reports	28 (100)	183 (100)	211 (100)
Indication
Stone ablation
Laser lithotripsy	28 (100)	125 (68.3)	153 (72.5)
Soft tissue ablation
Laser enucleation of the prostate	0 (0)	58 (31.7)	58 (27.5)
Clavien-Dindo grade (most severe complication for each report)
I	3 (10.7)	121 (66.1)	124 (58.8)
II	1 (3.6)	49 (26.8)	50 (23.7)
III	22 (78.6)	11 (6.1)	33 (15.6)
IV	2 (7.1)	1 (0.5)	3 (1.4)
V	0 (0)	0 (0)	0 (0)
Unknown	0 (0)	1 (0.5)	1 (0.5)
Complication relation to device malfunction
Not related	22 (78.6)	183 (100)	205 (97.2)
Possibly	3 (10.7)	0 (0)	3 (1.4)
Definitive	3 (10.7)	0 (0)	3 (1.4)

n = number of reports.

% = percentage of total reports for a particular laser generator. The total percentage of each subsection of the column should add up to 100%.

CD = Clavien-Dindo; Ho:YAG = holmium:yttrium-aluminum-garnet; MAUDE = manufacturer and user facility device experience; TFL = thulium fiber laser.

Table 2.

Breakdown of Intraoperative Complications Associated with HP Laser Generators on the MAUDE Database

Intraoperative complications	TFL (n, %)	Ho:YAG (n, %)	Total (n, %)
Indications	40 (100)	22 (100)	62 (100)
Stone ablation
Laser lithotripsy	32 (80.0)	11 (50.0)	43 (69.4)
Percutaneous nephrolithotomy	5 (12.5)	1 (4.5)	6 (9.7)
Bladder litholopaxy	1 (2.5)	1 (4.5)	2 (3.2)
Soft tissue ablation
Laser enucleation of the prostate	1 (2.5)	9 (40.9)	10 (16.1)
Transurethral resection of the bladder	1 (2.5)	0 (0)	1 (1.6)
Injury
Bladder mucosal injury	0 (0)	4 (18.2)	4 (6.5)
Case delayed/canceled	31 (77.5)	16 (72.7)	47 (75.8)
Foreign body in patient	1 (2.5)	0 (0)	1 (1.6)
Intrarenal hemorrhage	1 (2.5)	0 (0)	1 (1.6)
Pain	0 (0)	2 (9.1)	2 (3.2)
Thermal damage	4 (10.0)	0 (0)	4 (6.5)
Ureteral perforation	2 (5.0)	0 (0)	2 (3.2)
User harm	1 (2.5)	0 (0)	1 (1.6)
Intraoperative complication relation to device malfunction
Not related	8 (20.0)	4 (18.2)	12 (19.4)
Possibly	2 (5.0)	2 (9.1)	4 (6.5)
Definitive	30 (75.0)	16 (72.7)	46 (74.2)

n = number of reports.

% = percentage of total reports for a particular laser generator. The total percentage of each subsection of the column should add up to 100%.

Ho:YAG = holmium:yttrium-aluminum-garnet; HP = high-power; MAUDE = manufacturer and user facility device experience; TFL = thulium fiber laser.

We identified 62 reports covering 62 intraoperative complications and 210 reports covering 218 postoperative complications (Tables 2 and 3). Out of the 62 intraoperative complications, 51 (82.3%) involved stone ablation and 11 (17.7%) involved soft tissue ablation. The most common intraoperative complications were the delay or cancelation of the procedure after patient had been anesthetized (n = 47, 75.8%), followed by bladder mucosal damage (n = 4, 6.5%) and thermal injury (n = 4, 6.5%). Of the reports reviewed, 46 (74.2%) were definitively linked to device malfunction, 4 (6.5%) were possibly related, and 12 (19.4%) were not related.

Table 3.

Breakdown of Postoperative Complications Associated with HP Laser Generators on the MAUDE Database

Post-op adverse event*	TFL (n, %)	Ho:YAG (n, %)	Total (n, %)
Acute kidney injury	3 (9.7)	7 (3.7)	10 (4.6)
Avascularized ureter	1 (3.2)	0 (0)	1 (0.5)
Bacteremia	0 (0)	1 (0.5)	1 (0.5)
Bladder neck contracture	0 (0)	1 (0.5)	1 (0.5)
Blood transfusion	0 (0)	3 (1.6)	3 (1.4)
Capsular perforation	0 (0)	1 (0.5)	1 (0.5)
Chronic kidney disease	1 (3.2)	0 (0)	1 (0.5)
Clogged catheter	0 (0)	1 (0.5)	1 (0.5)
Clot retention	0 (0)	6 (3.2)	6 (2.8)
Ejaculatory dysfunction/dry orgasms	0 (0)	5 (2.7)	5 (2.3)
Fever	0 (0)	34 (18.2)	34 (15.6)
Hematuria	0 (0)	22 (11.8)	22 (10.1)
Hydronephrosis	0 (0)	1 (0.5)	1 (0.5)
Injury to renal pelvic epithelium	1 (3.2)	0 (0)	1 (0.5)
Kidney perforation	1 (3.2)	0 (0)	1 (0.5)
Laceration and damaged ureter	1 (3.2)	0 (0)	1 (0.5)
Lower urinary tract symptoms (LUTS)	0 (0)	2 (1.1)	2 (0.9)
Nausea	0 (0)	1 (0.5)	1 (0.5)
Obstructing stone fragment	0 (0)	3 (1.6)	3 (1.4)
Pain	0 (0)	2 (1.1)	2 (0.9)
Pyelonephritis	1 (3.2)	9 (4.8)	10 (4.6)
Renal colic	0 (0)	38 (20.3)	38 (17.4)
Renal failure	5 (16.1)	0 (0)	5 (2.3)
Sepsis	0 (0)	21 (11.2)	21 (9.6)
Unknown without Clavien Dindo grade	0 (0)	1 (0.5)	1 (0.5)
Ureteral stricture	17 (54.8)	7 (3.7)	24 (11.0)
Urinary retention	0 (0)	7 (3.7)	7 (3.2)
Urinary tract infection	0 (0)	14 (7.5)	14 (6.4)
Total	31 (100)	187 (100)	218 (100)

^*Each report/patient maybe have more than 1 complication.

n = number of reports.

% = percentage of total reports for a particular laser generator. The total percentage of each subsection of the column should add up to 100%.

Ho:YAG = holmium:yttrium-aluminum-garnet; HP = high-power; MAUDE = manufacturer and user facility device experience; TFL = thulium fiber laser.

Of the 210 reports of postoperative complications, we found 124 (59.1%) reports with the most severe complication being CD grade I, 50 (23.8%) reports with CD grade II, 33 (15.7%) reports with CD grade III, and 3 (1.4%) reports with CD grade IV related to sepsis or renal failure. No CD grade V complication was reported. Out of 218 postoperative complications, renal colic (n = 38, 17.4%) was the most common complication, followed by fever (n = 34, 15.6%) and ureteral strictures (n = 24, 11.0%). Of the postoperative reports reviewed, 3 (1.4%) were definitively linked to device malfunction, 3 (1.4%) were possibly related, and 205 (97.2%) were not related.

Holmium:yttrium-aluminum-garnet

We found 205 reports involving the HP Ho:YAG systems. 138 (67.3%) reports involved treatment of stones in various locations of the urinary system, while 67 (32.7%) reports involved ablation of soft tissues.

We identified 22 reports covering 22 intraoperative complications and 183 reports covering 187 postoperative complications. The 22 intraoperative complications consisted of canceled or delayed case (n = 16, 72.7%), bladder mucosal injury (n = 4, 18.2%), and pain under spinal anesthesia (n = 2, 9.1%). Of the 187 postoperative complications, the most common complications were renal colic (n = 38, 20.3%), fever (n = 34, 18.2%), and hematuria (n = 22, 11.8%). Regarding CD grades, we found 121 (66.1%) reports with the highest CD grade being grade I, 49 (26.8%) reports with grade II, 11 (6.0%) reports with grade III, 1 (0.5%) report with grade IV, and 1 (0.5%) report with unknown CD grade out of a total of 183 reports. The most common complications reported as CD grade III included ureteral strictures (n = 7) and obstructing stone fragments (n = 2). The one case of grade IV complication involved Intensive Care Unit admission due to impacted stone fragments and sepsis.

Thulium:yttrium-aluminum-garnet

In our analysis, we did not find any Tm:YAG cases that met inclusion criteria.

TFL

We found a total of 68 reports that involved HP TFL systems. Sixty-six (97.0%) reports involved stone ablation procedures, and 2 (2.9%) involved soft tissue ablation.

We were able to identify 40 reports covering 40 intraoperative complications and 28 reports covering 31 postoperative complications. Among the 40 intraoperative complications, the most common were delayed/canceled case (n = 31, 77.5%) and thermal damage (n = 4, 10.0%). The most common postoperative complication out of the total of 31 was ureteral stricture (n = 17, 54.8%), followed by renal failure (n = 5, 16.1%) and acute kidney injury (n = 3, 9.7%). We found 3 (10.7%) reports with the highest CD grade being grade I, 1 (3.6%) report with CD grade II, 22 (78.6%) reports with CD grade III, and 2 (7.1%) reports of grade IV. The most common complications reported as CD grade III included ureteral strictures (n= 17) and renal failure (n = 3). Both reports of grade IV complication were caused by severe, life-threatening renal failures.

We also analyzed the distribution of ureteral stricture reports chronologically before and after a well-publicized TFL system device recall in June 2021. Ten ureteral strictures took place between first clinical use of TFL in June 2020 and June 2021, with an annual rate of 10 strictures per year. Six ureteral strictures occurred between July 2021 and October 2024, making the annual rate of strictures 2.7 per year.

Discussion

HP laser generators have become more prevalent with recent technological advances, but their safety profile has yet to be evaluated clinically. Previous studies have reported on laser fibers and machines for the indication of stone ablation only,^7,8 and none has specifically looked at complications associated with emerging HP laser generators. Our study found an overall strong safety profile of HP Ho:YAG laser generators. We also found a high rate of CD grade III and IV complications and a high number of ureteral strictures associated with TFLs prior to July 2021, highlighting the need for urologists to exercise caution intraoperatively and monitor for relevant symptoms in postoperative care.

We identified a minimum number of perioperative complications regarding both HP laser systems. Most of these complications involved instrument malfunction prior to or during the procedure, which resulted in the delay or cancelation of the case without harm to the patient. Prolonged or unnecessary anesthesia episodes may pose short- and long-term risks, while delayed or canceled cases disrupt surgical planning—causing stress for patients and logistical burdens for hospitals. Although it is important for urologists to be well acquainted with the systems they operate to handle basic troubleshooting, additional preventative measures can include having immediate access to device manufacturer representatives for real-time support and preparing a spare laser unit for errors that cannot be promptly resolved. We have also seen a difference in the percentage of device-related complications between the intraoperative and postoperative reports. While speculative, this could be explained by the fact that perioperative complications-most commonly delayed or canceled cases-are more likely to be directly linked to device malfunction. In contrast, most postoperative complications, such as hematuria and strictures, are likely intrinsic to the laser procedure itself and less easily attributable to device failure.

HP Ho:YAG lasers are characterized by increased pulse energy and frequency settings, as well as pulse modulation features. Older Ho:YAG laser systems typically have a lower power output of less than 35 W and a frequency of 15–30 Hz, while the newer HP lasers can achieve 100 to 150 W of power output and frequency as high as 80 Hz.² HP Ho:YAG laser systems were theorized to be advantageous in urolithiasis due to their ability to produce smaller fragmentation of stones.⁹ However, clinical data so far regarding the efficacy and safety of HP Ho:YAG lasers lack a consensus. While Shrestha et al. found no difference in operative time and stone-free rates between HP and lower-power Ho:YAG in a 2022 prospective comparative study,¹⁰ a systematic review of HP vs. lower-power Ho:YAG laser settings during endoscopic stone treatment concluded that HP lasers were associated with a shorter total operative time and possibly improved stone-free rate.¹¹ In terms of safety, our study found a large number of reports on MAUDE regarding HP Ho:YAG generators, which potentially correlates with the longer and more prevalent clinical application of the instrument in both stone and soft tissue ablations. Most reports were felt to be unrelated to device malfunction. Despite the large number of reports, postoperative reports due to HP Ho:YAG generators were mostly minor, which is classified as CD grade II or less. The safety profile we found is congruent with the historic literature on the low rates of adverse outcomes of traditional, lower powered Ho:YAG laser systems, which included fever, sepsis, renal colic, and ureteral perforation.¹² While rare, presence of more severe complications, denoted by CD grade III and IV complications such as ureteral strictures and obstructing stone fragments, emphasizes the importance of continued risk counseling during the informed consent process. Notably, the single case of grade IV complication involved sepsis and impacted stone fragments that resulted in Intensive Care Unit admission, thus highlighting the need for appropriate perioperative antibiotic treatment and vigilant postoperative care.

Operating at 1940 nm, TFL has been theoretically proposed to offer energy per pulse as low as 0.025 J, deliver longer-pulse duration up to 12 ms, and emit energy that is more uniformly distributed.¹³ These characteristics can translate to decreased tissue penetration depth and carbonization, indicating a potentially better safety profile.¹⁴ A systematic review by Rice and Somani in 2021 had suggested promising but limited data on the application of TFL in soft tissue ablation as well as lithotripsy.¹⁴ However, we found a high frequency of CD grade III and IV complications involving the HP TFL systems. Most of these complications, though, were not thought to be related to device malfunctions. More than half of the postoperative complications involving HP TFL were ureteral strictures, with several cases progressing to clinically significant sequelae such as hydronephrosis, obstructive pyelonephritis, or renal failure. Ureteral stricture is not a rare complication of ureteroscopic lithotripsy; literature have reported the incident rate to be around 2.9%.¹⁵ However, it is a feared complication due to its potential to cause kidney damage and long term renal failure if not diagnosed and treated promptly. In a prospective comparative study, Para et al found that TFL was associated with a significantly higher incidence of ureteral strictures when compared with Ho:YAG.¹⁶ They theorized that due to the significantly higher water absorption coefficient of the TFL laser, soft tissue damage occurs more rapidly and takes the form of ureteral damage during laser lithotripsy. The discrepancy between the theoretical advantages of TFL and our observed clinical complications draws attention to the need for further prospective, randomized studies to optimize its use and improve patient outcomes.

In response to the high occurrence of ureteral strictures, one of the TFL manufacturers issued an emergency device recall in June 2021, recalling 408 units of the system in question.¹⁷ Their investigation revealed user error with power higher than the 20 W standard present, which exceeds the cooling power of irrigation fluids, as a main reason behind the injuries; they also suggested that stone impaction factored in as well. A software update was implemented and included a new preset of 8 W under the lithotripsy mode for sensitive anatomy such as the ureter. Our study found that there was a reduction in the annual reporting rate of ureteral stricture occurrence after the recall in June 2021 (Fig. 1), likely due to a combination of the product recall, user education, and familiarity with this novel laser device over time. Overall, these findings not only underscore the critical role of adverse event reporting systems like MAUDE and the industry’s prompt responsiveness but also highlight the necessity for continuous post-market surveillance and iterative improvements to ensure patient safety as new laser technologies are adopted.

FIG. 1.

Number of ureteral strictures associated with high-power TFL reported on the MAUDE database. MAUDE = manufacturer and user facility device experience; TFL = thulium fiber laser.

This study does have a number of limitations. First, the MAUDE database lacks information regarding the total number of procedures performed, making calculation or comparisons of complication rates impossible. Secondly, MAUDE database reports carry an intrinsic risk of reporting bias. In addition, our study did not identify any safety reports on the MAUDE database regarding Tm:YAG, and further studies regarding its real-world safety are warranted. Lastly, reports in MAUDE often vary in the level of detail provided, particularly regarding patient and outcome information. Key details such as patient demographics, comorbidities, follow-up on functional outcomes, and disease recurrence are frequently missing. Similarly, technical information on laser generator settings—such as energy, frequency, power, total energy used, and pulse duration—is inconsistently reported. This lack of standardized reporting makes it challenging to conduct a more detailed analysis of patient- or device-related factors contributing to complications and adverse events. Despite these challenges, the MAUDE database is a valuable source of information that, as demonstrated in our study, offers a real-world perspective on the safety and complications of emerging surgical techniques and instruments.

Conclusion

This is the first study that utilizes the MAUDE database to report on emerging HP laser systems in endourology. Our analysis shows that intraoperative complications using high-power laser systems were minimal. Most of the postoperative complications were not related to device malfunctions. Postoperative complications of Ho:YAG were mostly minor, while TFL showed a high rate of CD grade III and IV complications and a high number of ureteral strictures prior to July 2021. These findings indicate an overall strong safety profile in the real-world applications of high-power Ho:YAG lasers and highlight the reduction in the occurrence of ureteral strictures involving TFL with appropriate power settings.

Authors’ Contributions

B.X., Z.Q., and J.J.S. contributed to the conceptualization, methodology, and data curation of the study. B.X. performed the formal analysis and was primarily responsible for writing the original draft. B.X., J.J.S., and B.T. contributed to visualization and initial drafting. B.X., Z.Q., J.J.S., B.T., and D.A.W. provided critical revisions and helped with the review and editing of the manuscript. D.A.W. supervised the project and participated in both the conceptualization and review process.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

Data Availability Statement

The dataset used in this study is publicly available at:

Abbreviations

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