MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. MICRO BIPOLAR FORCEPS MCL340 WL 210MM; PFM11

Catalog Number	MCL340
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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 the micro bipolar forceps mcl340 wl 210mm (mcl340), heats up too quickly and carbonizes.It is unknown whether there was patient involvement; however, no injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The micro bipolar forceps mcl340 wl 210mm (mcl340) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the investigation shows no malfunction of the forceps; the electrical test is compliant.The forceps do not generate any current; the current used during an intervention comes from a generator.There is no problem with this instrument.Root cause analysis: the reported complaint was not confirmed.According to the customer, the forceps heat up too quickly and carbonize.The investigation shows no malfunction of the forceps; the electrical test is compliant.The fact that the clamp heated up too quickly and carbonization occurred is undoubtedly due to the generator's intensity being too high.

• Brand Name: MICRO BIPOLAR FORCEPS MCL340 WL 210MM
• Common Device Name: PFM11
• 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: 22824533
• Report Number: 3003249645-2025-00037
• Device Sequence Number: 19974646
• Product Code: GEI
• UDI-Device Identifier: 10381780105565
• UDI-Public: 10381780105565
• 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): 09/04/2025

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: MCL340
• Device Lot Number: 7457428
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/17/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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