MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV134 BIPOLAR 350MM MOUIEL; PFM16

Catalog Number	CEV134
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the blades of the 350mm mouiel bipolar forceps (cev134) were brought together to coagulate, they do not close properly in parallel, thus affecting their action.It was reported that because the forceps was not working, there was an increase in surgery time of more than 30 minutes.It was reported that staff used bipolar forceps from the competitor to complete the procedure.No patient injury or death was reported.
Additional Manufacturer Narrative
End user: (b)(6).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
N/a.
Additional Manufacturer Narrative
Updated fields: the 350mm mouiel bipolar forceps (cev134) 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 forceps verified the problem statement as confirmed.When closing the handle, the two electrode jaws do not completely touch each other, the clamp does not pass through the smooth ring control system which simulates a trocar.After unscrewing the electrodes from the handle, it was noticed that the electrodes could be pushed in further, and that the jaws closed properly at this point.It was also noted that the inside of the screwdriver head was slightly damaged.Root cause analysis: it was determined that the electrodes were not screwed in sufficiently, probably because the screw head was slightly damaged.This caused the electrodes to slide forward during sterilization and use which prevented the two jaws from closing completely.The tests during the final inspection were compliant (passage through the smooth ring 5 mm) because the electrodes had not yet moved.The torque wrench screwing control could have been biased due to the damaged screw head.

• Brand Name: FORCEPS CEV134 BIPOLAR 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: 21885243
• Report Number: 3003249645-2025-00014
• Device Sequence Number: 8098177
• Product Code: GEI
• UDI-Device Identifier: 10381780091837
• UDI-Public: 10381780091837
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2025

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: CEV134
• Device Lot Number: 7456728
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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