MAUDE Adverse Event Report: ETHICON INC. 4M.M. ELECTRODE FOR BIPOLAR RE; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR

Catalog Number 01942

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

Patient Problems Uterine Perforation (2121); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure? date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? please advise what is meant by ¿the patient moved up with her body off the table¿? was the uterine perforation confirmed by hysteroscopy or laparoscopy? what was the size and location? any pictures available? how was the uterine perforation treated? if any surgical intervention was performed, please provide details.Please provide additional information ¿bowel damaged¿.Was medical or surgical intervention for the ¿bowel damage¿? please provide clarification regarding ¿going further laparoscopically¿? is another intervention planned? if so, please provide date.Product code and lot #? will product be returned? if yes please provide return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? does the surgeon believe there was any alleged deficiency with the device? did the versapoint electrode cause the uterine perforation and bowel injury?.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the electrosurgical device was used.During surgery with 4mm liss, the patient moved up with her body off the table.It was also reported that the exact reason for this is unknown.But because of this or maybe already during surgery, the uterus was perforated and a bowel was damaged.The patient is now doing well and is still in hospital for observation.Currently the doctor is looking at what caused this.And it was reported that it is going further laparoscopically.Additional information has been requested.

• Brand Name: 4M.M. ELECTRODE FOR BIPOLAR RE
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; st. mellons; cardiff
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8393282
• MDR Text Key: 137932984
• Report Number: 2210968-2019-79286
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K111751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention