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

Model Number	0638-800-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Urinary Retention (2119); Hematuria (2558); Urethral Stenosis/Stricture (4501); Unspecified Tissue Injury (4559); Urinary Incontinence (4572)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in the international brazilian journal of urology that a study was conducted to assess the efficacy and safety of holmium laser enucleation of the prostate (holep) in patients with high comorbidity burden.A total of out of 305 cases of patients were studied.The following boston scientific products were used during the procedures: versacut morcellator, versapulse 120w and accumax 550 laser fiber.According to the study results, 10 and 20 patients experimented bladder mucosal damage and capsule perforation, respectably as intraoperative complications.Regarding postoperative complications, for 10 patients a blood transfusion was necessary, 1 patient experienced postoperative fever and it was needed to replace vesical catheter and 8 patients suffered orchiepididymitis (inflammation of the epididymis and/or testicle).Two patients developed urinary retention and 4 patients required a clot retention.Urinary incontinence at 3 months was also presented in 6 patients and 4 patients required a reintervention for a urethral stricture.
Event or Problem Description
It was reported in the international brazilian journal of urology that a study was conducted to assess the efficacy and safety of holmium laser enucleation of the prostate (holep) in patients with high comorbidity burden.A total of out of 305 cases of patients were studied.The following boston scientific products were used during the procedures: versacut morcellator, versapulse 120w and accumax 550 laser fiber.According to the study results, 10 and 20 patients experimented bladder mucosal damage and capsule perforation, respectably as intraoperative complications.Regarding postoperative complications, for 10 patients a blood transfusion was necessary, 1 patient experienced postoperative fever and it was needed to replace vesical catheter and 8 patients suffered orchiepididymitis (inflammation of the epididymis and/or testicle).Two patients developed urinary retention and 4 patients required a clot retention.Urinary incontinence at 3 months was also presented in 6 patients and 4 patients required a reintervention for a urethral stricture.
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 implant of 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.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 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: 19525113
• Report Number: 2124215-2024-35965
• Device Sequence Number: 20720407
• Product Code: GEX
• UDI-Device Identifier: 07290109140582
• UDI-Public: 07290109140582
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 0638-800-00
• Device Catalogue Number: 0638-800-00
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCUMAX LASER FIBERS; ACCUMAX LASER FIBERS; VERSACUT MORCELLATOR; VERSACUT MORCELLATOR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown