MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. BIPOLAR INSERT CEV634-1A 350MM MOUIEL; PFM16

Catalog Number	CEV634-1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported that bipolar forceps of the bipolar insert cev634-1a 350mm mouiel (cev634-1a) broke inside the patient during an operation.It was reported that the break occurred at the tip of the insert, a single piece detached and was recovered, and another forceps were used to complete the surgery.There was no injury, death, and it was unknown if there was any increase in surgery time.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h3, h6, h11.The bipolar insert cev634-1a 350mm mouiel (cev634-1a) was returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the product was returned, and the investigation shows the jaw was broken, however, the insert (cev634-1a) had been repaired and modified externally by another company.The markings were worn off, the coating was not microfrance, the jaws were different from micro france, as was the ribbing.Root cause analysis: the product was returned, and the investigation revealed that the electrode jaw was broken, and that this cev634-1a insert had been repaired and modified by another company.The modification and repair of the instrument were carried out by a third party not qualified by integra microfrance (imf).Imf recommends repairs within its factory and cannot guarantee the services provided by an eternal service provider.

• Brand Name: BIPOLAR INSERT CEV634-1A 350MM MOUIEL
• 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: 23834997
• Report Number: 3003249645-2025-00057
• Device Sequence Number: 17413513
• Product Code: GEI
• UDI-Device Identifier: 10381780094678
• UDI-Public: 10381780094678
• 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,Followup
• Report Date (Section B): 02/04/2026

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: CEV634-1A
• Device Lot Number: 6843522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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