MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN DISP FCPS 9IN,1.0MM; VERSATRU DISPOSABLE FORCEPS

Model Number	9009100ST
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a disposable forceps ((b)(4)) sparked and charred when physician tested them prior to use.A 5-10 minutes delay was noted and no patient injury reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The disposable forceps (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 9009100st with lot 5902192, conformed to the specifications when released to stock.Failure analysis - a visual inspection showed one tip was damaged with signs of charring.A fluke multimeter was used to test the tips continuity.One tip passed the continuity test but the charred tip did not pass.The complaint condition is confirmed.The possible root cause could come from an error of use as indicated on the ifu (instructions for use): do not exceed 24 watts (80 malis units) or 450 volts peak to peak in coag mode.Failure to observe mode and setting warnings may reduce efficacy of non-stick performance, result in unintended burns, and/or cause failure of device insulations.
Event or Problem Description
N/a.

• Brand Name: CODMAN DISP FCPS 9IN,1.0MM
• Common Device Name: VERSATRU DISPOSABLE FORCEPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14084162
• Report Number: 3013886523-2022-00147
• Device Sequence Number: 11299716
• Product Code: GEI
• UDI-Device Identifier: 10381780521679
• UDI-Public: (01)10381780521679(17)241031(10)5902192
• Combination Product (Y/N): N
• PMA/510(K) Number: K162469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 9009100ST
• Device Catalogue Number: 9009100ST
• Device Lot Number: 5902192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown