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

Model Number UNK-P-VERSACUT_MORCELLATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Dae hyun kim, chang suk kang, jae whi choi, seong uk jeh, see min choi, chun woo lee, sung chul kam, jeong seok hwa, and jae seog hyun.The efficacy and safety of 'inverted omega en-bloc' holmium laser enucleation of the prostate (holep) for benign prostatic hyperplasia: a size-independent technique for the surgical treatment of luts.World j mens health published online apr 3, 2023.Https://doi.Org/10.5534/wjmh.220225.

Event Description

It was reported to boston scientific via an article published in the world journal of men's health that a retrospective review was conducted of the patients who had undergone an inverted oment en-bloc holmium laser enucleation of the prostate (holep) to evaluate the safety and efficacy of this method for the treatment of benign prostate hyperplasia (bph) with lower urinary tract symptoms (luts).The medical records of 716 patients who underwent inverted omega en-bloc holep between 2014 and 2021 were reviewed.All procedures were performed by a single surgeon and were formed using a 100w holmium:yttrium-aluminum-garnet laser system with a 550 micron end-firing laser fiber and a verscut tissue morcellator.There were no major life-threatening complications that occurred during the procedures.Following the procedures, the following complications were reported: 11 patients had urethral stricture, 12 patients had bladder neck contracture, 14 patients had urinary incontinence, and 4 patients experienced bladder injuries from the morcellator.The following procedures were done to surgically manage the complications reported: 9 patients underwent urethral sounding, 2 patients underwent endoscopic internal urethrotomy, 12 patients underwent an additional holep procedure to treat the bladder neck contractures, and 15 patients underwent an additional holep procedure to treat regrowing adenomas.Additionally, the following postoperative medicals exceeding six months were: 22 patients required alpha blockers, 16 patients required cholinergics, 58 patients required anticholoinergics or beta-3 agonists, 18 patients required antidiuretics, and 38 patients required daily pde-5 inhibitors.This event is for the versacut morecellator.

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.Dae hyun kim, chang suk kang, jae whi choi, seong uk jeh, see min choi, chun woo lee, sung chul kam, jeong seok hwa, and jae seog hyun.The efficacy and safety of 'inverted omega en-bloc' holmium laser enucleation of the prostate (holep) for benign prostatic hyperplasia: a size-independent technique for the surgical treatment of luts.World j mens health published online apr 3, 2023.Https://doi.Org/10.5534/wjmh.220225.

Event Description

It was reported to boston scientific via an article published in the world journal of men's health that a retrospective review was conducted of the patients who had undergone an inverted oment en-bloc holmium laser enucleation of the prostate (holep) to evaluate the safety and efficacy of this method for the treatment of benign prostate hyperplasia (bph) with lower urinary tract symptoms (luts).The medical records of 716 patients who underwent inverted omega en-bloc holep between 2014 and 2021 were reviewed.All procedures were performed by a single surgeon and were formed using a 100w holmium:yttrium-aluminum-garnet laser system with a 550 micron end-firing laser fiber and a verscut tissue morcellator.There were no major life-threatening complications that occurred during the procedures.Following the procedures, the following complications were reported: 11 patients had urethral stricture, 12 patients had bladder neck contracture, 14 patients had urinary incontinence, and 4 patients experienced bladder injuries from the morcellator.The following procedures were done to surgically manage the complications reported: 9 patients underwent urethral sounding, 2 patients underwent endoscopic internal urethrotomy, 12 patients underwent an additional holep procedure to treat the bladder neck contractures, and 15 patients underwent an additional holep procedure to treat regrowing adenomas.Additionally, the following postoperative medicals exceeding six months were: 22 patients required alpha blockers, 16 patients required cholinergics, 58 patients required anticholinergics or beta-3 agonists, 18 patients required antidiuretics, and 38 patients required daily pde-5 inhibitors.This event is for the versacut morcellator.

• Brand Name: VERSACUT
• Type of Device: 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: 17907796
• MDR Text Key: 325338716
• Report Number: 2124215-2023-56075
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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
• Device Operator: Health Professional
• Device Model Number: UNK-P-VERSACUT_MORCELLATOR
• Device Catalogue Number: UNK-P-VERSACUT_MORCELLATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention