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 Perforation (2001)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

B.3 date of event: date of the article was used.D3/g1 additional email: (b)(6).(b)(6).

Event Description

It was reported to boston scientific, in an article published in the international neurology journal, that a study was performed to identify risk factors for transurethral coagulation (tuc) using bipolar electrocautery for hemostasis during holmium laser enucleation of the prostate (holep) surgery for benign prostatic hyperplasia (bph).The clinical outcomes of the holep surgery were performed by a single surgeon between (b)(6) 2010 and (b)(6) 2020 at the seoul national university hospital.Patient characteristics and perioperative parameters were used to identify the risk factors for tuc.The tuc group was defined as a case of conversion to hemostasis using electrocautery during the hemostasis step after enucleation.Of 1563 patients, 357 underwent tuc, 299 patients underwent adjuvant tuc, while 58 patients underwent salvage tuc and 1206 did not (non-tuc group).Tuc procedure with prostate enucleation was performed using a 26f resectoscope (karl storz) with a 550-laser fiber (slimline).An 80w ho:yag laser machine (versapulse power-suite) was used, and the energy power was usually set to 2.0 j and 40 hz.Morcellation was performed using a (versacut mechanical morcellator).Non-tuc procedure with prostate enucleation was performed using a 26f resectoscope (karl storz) with a 550-laser fiber (slimline).An 80w ho:yag laser machine (versapulse power-suite) was used, and the energy power was usually set to 2.0 j and 40 hz.Among the preoperative factors, there were significant differences between the two groups in prostate-specific antigen (psa), total prostate volume (tpv), and transition zone volume (tzv).The tuc group had higher psa, larger tpv, and larger tzv than non-tuc group.Except for intraoperative capsule perforation, all intraoperative parameters, including operative time, enucleation time, morcellation time, and enucleation weight were significantly larger in the tuc group than in the non-tuc group.Out of 357 patients that underwent a tuc two patient presented with intraoperative capsule perforation and out 1,206 patient that underwent a non-tuc five patients presented with intraoperative capsule perforation.During the 2- week postoperative follow-up, pvr was significantly higher in the tuc group, but there was no significant difference between the 2 groups in total international prostate symptom score (ipss), quality of live (qol) score, and maximum flow rate (qmax).Regarding the postoperative follow-up results at 3 months and 6 months, none of the postoperative factors showed any significant difference between the 2 groups.

Event Description

It was reported to boston scientific, in an article published in the international neurology journal, that a study was performed to identify risk factors for transurethral coagulation (tuc) using bipolar electrocautery for hemostasis during holmium laser enucleation of the prostate (holep) surgery for benign prostatic hyperplasia (bph).The clinical outcomes of the holep surgery were performed by a single surgeon between january 2010 and april 2020 at the seoul national university hospital.Patient characteristics and perioperative parameters were used to identify the risk factors for tuc.The tuc group was defined as a case of conversion to hemostasis using electrocautery during the hemostasis step after enucleation.Of 1563 patients, 357 underwent tuc, 299 patients underwent adjuvant tuc, while 58 patients underwent salvage tuc and 1206 did not (non-tuc group).Tuc procedure with prostate enucleation was performed using a 26f resectoscope (karl storz) with a 550-laser fiber (slimline).An 80w ho:yag laser machine (versapulse power-suite) was used, and the energy power was usually set to 2.0 j and 40 hz.Morcellation was performed using a (versacut mechanical morcellator).Non-tuc procedure with prostate enucleation was performed using a 26f resectoscope (karl storz) with a 550-laser fiber (slimline).An 80w ho:yag laser machine (versapulse power-suite) was used, and the energy power was usually set to 2.0 j and 40 hz.Among the preoperative factors, there were significant differences between the two groups in prostate-specific antigen (psa), total prostate volume (tpv), and transition zone volume (tzv).The tuc group had higher psa, larger tpv, and larger tzv than non-tuc group.Except for intraoperative capsule perforation, all intraoperative parameters, including operative time, enucleation time, morcellation time, and enucleation weight were significantly larger in the tuc group than in the non-tuc group.Out of 357 patients that underwent a tuc two patient presented with intraoperative capsule perforation and out 1,206 patient that underwent a non-tuc five patients presented with intraoperative capsule perforation.During the 2- week postoperative follow-up, pvr was significantly higher in the tuc group, but there was no significant difference between the 2 groups in total international prostate symptom score (ipss), quality of live (qol) score, and maximum flow rate (qmax).Regarding the postoperative follow-up results at 3 months and 6 months, none of the postoperative factors showed any significant difference between the 2 groups.

Manufacturer Narrative

B.3 date of event: date of the article was used hyun sik yoon, min hyuk kim, jae suk park, min soo choo, seong jin jeong, seung-june oh.Risk factors for transurethral coagulation for hemostasis during holmium laser enucleation of the prostate.Int neurourol j 2022;26(2):153-160 https://doi.Org/10.5213/inj.2142414.207 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: 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.; hakidma st 6; 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: 17962074
• MDR Text Key: 326006488
• Report Number: 2124215-2023-55661
• 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: 12/19/2023

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: Not provided
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: VERSAPULSE POWERSUITE 80W; VERSAPULSE POWERSUITE 80W
• Patient Outcome(s): Other