MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. AFORCEPS MCL18 ALLIG CVD RT BOUCHAYER; PFM11

Catalog Number	MCL18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the allig cvd rt bouchayer forceps (mcl18) broke during a surgical procedure.No patient injury, death or surgical delay has been reported.
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
N/a.
Additional Manufacturer Narrative
End-user facility: (b)(6) hospital.Additional b5 narrative: it was reported that during the procedure, the alligator forceps was given to the surgeon with a surgical patty on it."from movement to the patient and back to my table, the instrument broke".Staff initially thought a piece had fallen inside the patient's cavity.This delayed the staff as the surgeon had to then look with the scope to ensure it was not inside.Once this was confirmed whilst the patient was still on the table, staff had to get a magnet out on the floor to find the broken part, which they had confirmed was recovered from the floor.No significant delay in surgery has been reported.There was no injury to the patient.The customer reported that the device has been discarded.
Additional Manufacturer Narrative
The alligator curved rt bouchayer forceps (mcl18) was not returned to the manufacturer, and no photos were provided by the customer.Therefore, an investigation for cause was unable to be performed.According to the customer the device broke during a surgical procedure and the broken piece was found on the ground.A possible root cause for this failure is that too much force was likely applied to the instrument which could have caused it to break.However, a definitive root cause could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: AFORCEPS MCL18 ALLIG CVD RT BOUCHAYER
• 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: 21404022
• Report Number: 3003249645-2025-00004
• Device Sequence Number: 15798322
• Product Code: GEI
• UDI-Device Identifier: 10381780105121
• UDI-Public: 10381780105121
• Combination Product (Y/N): N
• PMA/510(K) Number: K993655
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2025

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: MCL18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 03/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/15/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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