MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. 360MM GAYET BIPOLAR FORCEPS; PFM16

Catalog Number	CEV134BG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 360mm gayet bipolar forceps (cev134bg) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Evaluation of the bipolar forceps verified the complaint reported by the customer as valid.It was suspected that when going to after-sales service, the screw was not welded which led to the loss of the screw.It was noted that this was an isolated occurrence and a reminder was sent to the service and repair team.
Event or Problem Description
It was reported that the clamp/360mm gayet bipolar forceps (cev134bg) "broke at the handle where the screw was unscrewed and was gone".The clamp reportedly broke in the patient.There was no consequences to the patient but an unspecified delay in care occurred.When asked if the procedure was completed using a another device or method, customer replied that they have a stock of tweezers that they have set up following breakages.It was not reported whether all parts were retrieved.

• Brand Name: 360MM GAYET BIPOLAR FORCEPS
• Common Device Name: PFM16
• Manufacturer (Section D): INTEGRA MICROFRANCE S.A.S.; le pavillon; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer (Section G): INTEGRA MICROFRANCE S.A.S.; le pavillon; saint aubin le monial 03160 ; FR 03160
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20832681
• Report Number: 3003249645-2024-00057
• Device Sequence Number: 18359002
• Product Code: GEI
• UDI-Device Identifier: 10381780091844
• UDI-Public: 10381780091844
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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 Catalogue Number: CEV134BG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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