MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN SLIM DISP FCPS 9IN,0.5MM; VERSATRU DISPOSABLE FORCEPS

Catalog Number 9009050SL

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

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

It was reported that versatru bipolar forceps was used for the first time and the tip was not correctly aligned and seemed they were scissoring.No further information was provided by the hospital.There was no patient injury nor surgical delay.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d10, g1, g4, g7, h2, h3, h4, h6, h10 unique device identifier (udi)-(b)(4).Codman disposable forcep was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN SLIM DISP FCPS 9IN,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: 9272645
• MDR Text Key: 191853729
• Report Number: 1226348-2019-00517
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9009050SL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1