MAUDE Adverse Event Report: ETHICON INC. 4.0MM VERSAPOINT RESECTING LOO; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR

Catalog Number 01942

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did any part of the electrode break or did it just become loose? did any pieces fall inside the patient? if so, were the pieces successfully retrieved without additional dissection? will the product be returned? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent surgical hysteroscopy with calcified myomectomy on (b)(6) 2020 and an electrode was used.During the procedure there was damage to the electrode in a bipolar loop and a part of it loosened inside the patient.The procedure was completed using a new like device and there were no adverse patient consequences reported.Additional information will be requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/15/2020.Additional information was requested and the following was obtained: did any part of the electrode break or did it just become loose? just let go.Did any pieces fall inside the patient? yes.If so, were the pieces successfully retrieved without additional dissection? no.Will the product be returned? no, was discarded.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/28/2020.H6 component code: g07002 - device not returned.Photo analysis: only a picture was returned for analysis.Upon visual inspection of the picture, a detached electrode could be observed however, no conclusion could be reached on how this happens as the sample was not returned for analysis.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Product release date: april 2020.Product expiry date: april 2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 4.0MM VERSAPOINT RESECTING LOO
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10733694
• MDR Text Key: 213003916
• Report Number: 2210968-2020-08323
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01942
• Device Lot Number: UGY2004012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/17/2020; 12/08/2020
• Supplement Dates FDA Received: 12/15/2020; 12/28/2020
• Patient Sequence Number: 1
• Patient Age: 43 YR