MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV420 DIA 10MM BABCOCK DELAITRE; MICROFRANCE INSTRUMENTS

Catalog Number	CEV420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a laparoscopic surgery, the forceps cev420 dia 10mm babcock delaitre (cev420) broke without any shock or trauma, and the broken parts of the jaw were discovered in the patient¿s abdomen.The broken parts were retrieved.There was no patient injury or death, and less than 30 minutes increase in surgical time was 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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The forceps cev420 dia 10mm babcock delaitre (cev420) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the moving jaw of the returned forceps was broken.At the point of rupture, a darker area is observed, corresponding to a pre-fracture.Root cause analysis: this area of the breakage was typical of a pre-existing weakness in the material.This weakness was likely due to the initial presence of an inclusion or internal defect, which acted as a crack initiation point.During successive uses of the instrument (the instrument was 15 years old), this weakness facilitated the initiation and propagation of the crack, leading to the final rupture.
Event or Problem Description
N/a.

• Brand Name: FORCEPS CEV420 DIA 10MM BABCOCK DELAITRE
• 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: 24589356
• Report Number: 3003249645-2026-00005
• Device Sequence Number: 21178623
• Product Code: GCJ
• UDI-Device Identifier: 10381780093084
• UDI-Public: 10381780093084
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: CEV420
• Device Lot Number: 201110MF1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2011
• 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