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	01/16/2025
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
It was reported that the 350mm mouiel bipolar insert (cev634-1a) broke in the patient's abdomen and was difficult to retrieve.Staff managed to finish the surgery.It was reported that the increase in surgery time was less than 30 minutes.
Additional Manufacturer Narrative
The 350mm mouiel bipolar insert (cev634-1a) was returned for evaluation.The device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the bipolar insert verified the problem statement as confirmed.The electrode was broken at the black joint with the tube.This area was reduced and therefore more flexible to allow crimping with the tubes and the black ring.Under a magnifying glass, the beginning of breakage can be seen in the darkest area of the metal fibers.Root cause analysis: for potential root causes, it was determined that the beginning of breakage was likely linked to wear and tear related to the product life cycle.The fragility was undoubtedly accentuated by the cutting direction of the electrodes on the stainless-steel plate perpendicular to the fibers.Corrective action is currently underway to address electrode-related issues.
Event or Problem Description
N/a.

• 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: 21360610
• Report Number: 3003249645-2025-00002
• Device Sequence Number: 15562846
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 6388381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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