MAUDE Adverse Event Report: LUMENIS LTD VERSAPULSE POWERSUITE; POWERED LASER SURGICAL INSTRUMENT

Model Number	0638-809-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Septic Shock (2068); Unspecified Tissue Injury (4559)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific via an article presented at the 112th annual meeting of the japanese urological association that a retrospective evaluation was conducted to evaluate the surgical outcomes of transurethral lithotripsy (tul) at the todachuo general hospital.A total of 86 patients with a median age of 58 years (range, 16-87 years) who underwent tul between april 2023 and june 2024 were evaluated.The participants included 57 males and 29 females.Prophylactic antibiotics were administered preoperatively to patients with positive urine cultures or those at high risk of infection.The target stones were located on the right side, left side, or in a transplanted kidney.Pre-stenting was performed in 36 cases, with 25 cases due to stone-induced pyelonephritis, and 4 due to difficult ureters from prior surgeries.The median longest diameter of the stones was 8 mm (range, 3-17 mm), and the median shortest diameter was 6.5 mm (range, 2-16 mm).There were 29 rigid-tul cases and 57 flexible-tul cases.The median surgical time was 68 minutes (range, 20-159 minutes).The stone-free rate was 90.6 %.Perioperative complications included ureteral injury in 9 cases, postoperative pyelonephritis or septic shock in 4 cases.All 4 cases had positive preoperative urine cultures, and 2 had surgical times exceeding two hours.Close consideration of each case preoperatively and accurate surgical techniques are crucial for safe operation and the prevention of the postoperative complications.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Tachiki, a., & yagisawa, t.(2025).Surgical outcomes of transurethral lithotripsy at our institution.112th annual meeting of the japanese urological association.
Event or Problem Description
It was reported to boston scientific via an article presented at the 112th annual meeting of the japanese urological association that a retrospective evaluation was conducted to evaluate the surgical outcomes of transurethral lithotripsy (tul) at the todachuo general hospital.A total of 86 patients with a median age of 58 years (range, 16-87 years) who underwent tul between april 2023 and june 2024 were evaluated.The participants included 57 males and 29 females.Prophylactic antibiotics were administered preoperatively to patients with positive urine cultures or those at high risk of infection.The target stones were located on the right side, left side, or in a transplanted kidney.Pre-stenting was performed in 36 cases, with 25 cases due to stone-induced pyelonephritis, and 4 due to difficult ureters from prior surgeries.The median longest diameter of the stones was 8 mm (range, 3-17 mm), and the median shortest diameter was 6.5 mm (range, 2-16 mm).There were 29 rigid-tul cases and 57 flexible-tul cases.The median surgical time was 68 minutes (range, 20-159 minutes).The stone-free rate was 90.6 %.Perioperative complications included ureteral injury in 9 cases, postoperative pyelonephritis or septic shock in 4 cases.All 4 cases had positive preoperative urine cultures, and 2 had surgical times exceeding two hours.Close consideration of each case preoperatively and accurate surgical techniques are crucial for safe operation and the prevention of the postoperative complications.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Tachiki, a., & yagisawa, t.(2025).Surgical outcomes of transurethral lithotripsy at our institution.112th annual meeting of the japanese urological association.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22006475
• Report Number: 2124215-2025-30013
• Device Sequence Number: 9099329
• Product Code: GEX
• UDI-Device Identifier: 07290109140568
• UDI-Public: (01)07290109140568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0638-809-01
• Device Catalogue Number: 0638-809-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown