MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN DISP FCPS 8IN,0.5MM; VERSATRU DISPOSABLE FORCEPS

Catalog Number 9008050ST

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that there was a scorching on the tip of the codman disposable forceps that became severe during the procedure.Therefore, it was changed to a new one and the procedure was completed.No patient injury was reported and the event did not lead to surgical delay.

Manufacturer Narrative

The forcep was returned for evaluation.Device history record (dhr) - lot number 4545766, showed 1 non-conformity that have been processed before the batch was released to stock on 21 aug.2020.The non-conformity reported issue had no link to this complaint.Failure analysis - one versatru forcep was returned for evaluation with no visual abnormalities observed.A multimeter was used to measure the resistance between 2 points along each tine.Both tines did not show any continuity failure.Therefore, this complaint is not confirmed.The complaint condition could not be replicated.The device did not contribute to the complaint condition.The device met specifications.The device was returned for evaluation and has been investigated.The investigation concluded that the device met specifications and complaint condition could not be replicated.The possible root cause for "physician felt scorching on the tip of device got severe during the procedure" reported by the customer could be linked to device using and/or user error: "improper use of generator (power too elevated)".

• Brand Name: CODMAN DISP FCPS 8IN,0.5MM
• Type of Device: VERSATRU DISPOSABLE FORCEPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11097404
• MDR Text Key: 230316212
• Report Number: 3013886523-2020-00291
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K162469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 9008050ST
• Device Lot Number: 4545766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1