MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV525 FENESTRATED 20MM JAWZ; MICROFRANCE INSTRUMENTS

Catalog Number	CEV525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/13/2026
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 during a laparoscopic cholecystectomy, the forceps cev525 fenestrated 20mm jawz (cev525), " broke at the jaw for no apparent reason.The broken and detached piece of forceps remained momentarily inside the patient's abdomen." it was reported that the broken pieces were retrieved, and there were no consequences to the patient, time, or material loss.No jury or death reported.

• Brand Name: FORCEPS CEV525 FENESTRATED 20MM JAWZ
• Common Device Name: MICROFRANCE INSTRUMENTS
• 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: 24815814
• Report Number: 3003249645-2026-00010
• Device Sequence Number: 9686503
• Product Code: GCJ
• UDI-Device Identifier: 10381780093749
• UDI-Public: 10381780093749
• Combination Product (Y/N): N
• PMA/510(K) Number: K080257
• 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): 05/12/2026

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: CEV525
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2019
• 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