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 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date it has been reported that the device will not be 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 a hysteroscopy surgery for myoma removal on (b)(6) 2020 and an electrode was used.During the procedure, the tip of the electrode broke.No fragments were generated and the procedure was completed using a new like device.There were no adverse patient consequences.No further information is available.

Manufacturer Narrative

(b)(4).Date sent to fda: 01/25/2021.H6 component code: g07002 - device not returned.The device history record for batch referenced above was reviewed for non-conformances related to the nature of the complaint during the manufacturing process.The results of this review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.Product release date: february 2020.Product expiry date: december 2024.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: 10878399
• MDR Text Key: 218246525
• Report Number: 2210968-2020-09175
• 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
• Type of Report: Initial,Followup
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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: UGY1912082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1