MAUDE Adverse Event Report: LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0637-245-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Urinary Retention (2119); Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	07/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article document: taro banno, md, kazutaka nakamura, yudai kaneda, akihiko ozaki, yukiko kouchi, tadashi ohira and hiroaki shimmura.Detection rate and variables associated with incidental prostate cancer by holmium laser enucleation of the prostate.International journal of urology 2022;29;860-865.Date of event: the earliest procedure date was used as event date.
Event or Problem Description
It was reported in the international journal of urology that a study was conducted to examine the detection rate of incidental prostate cancer by holmium laser enucleation of the prostate (holep) and variables associated with them.The procedure was performed using the lumenis versacut morcellator system.The data of 612 patients who underwent a holep procedure between (b)(6) 2013 and (b)(6) 2021 were retrospectively reviewed.Postoperatively, urinary tract infection, hematuria, urinary retention, and perforation of bladder or prostate were seen in 32, 22, 15, and 6 cases, respectively for 3 days of postoperative hospitalization.
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.
Event or Problem Description
It was reported in the international journal of urology that a study was conducted to examine the detection rate of incidental prostate cancer by holmium laser enucleation of the prostate (holep) and variables associated with them.The procedure was performed using the lumenis versacut morcellator system.The data of 612 patients who underwent a holep procedure between july 2013 and september 2021 were retrospectively reviewed.Postoperatively, urinary tract infection, hematuria, urinary retention, and perforation of bladder or prostate were seen in 32, 22, 15, and 6 cases, respectively for 3 days of postoperative hospitalization.

• Brand Name: VERSACUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 19536609
• Report Number: 2124215-2024-32891
• Device Sequence Number: 6424898
• Product Code: GCJ
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050639
• 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): 07/11/2024

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: 0637-245-01
• Device Catalogue Number: 0637-245-01
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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: P120; P120; SLIMLINE FIBERS; SLIMLINE FIBERS; VPPS SERIES; VPPS SERIES
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown