MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV525 FENESTRATED 20MM JAWZ; PFM16

Catalog Number	CEV525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic inguinal hernia procedure, the forceps cev525 fenestrated 20mm jawz (cev525) protective sheath degraded intra-abdominally.It was reported that "a stripping of the fenestrated forceps is observed, requiring recovery of the material left intra-abdominally.Recovery of its components appears complete." an x-ray was not performed to verify that all parts were retrieved, as the material is nonopaque plastic and therefore not visible on x-ray.A visual check confirmed that all parts had been retrieved.No patient injuries or deaths were reported; however, a 20-minute increase in surgery time was noted.
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
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The forceps cev525 fenestrated 20mm jawz (cev525) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned evidence was evaluated, and the reported problem was verified.The tube sheath was broken by approximately 1.5 cm, and a piece of the sheath was missing.Root cause analysis: the reported complaint was confirmed.The tube sheath was broken, probably due to an impact during cleaning, which weakened it and caused it to break during the operation.The instrument was probably not checked sufficiently before commissioning for the operating room.

• Brand Name: FORCEPS CEV525 FENESTRATED 20MM JAWZ
• 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: 22564349
• Report Number: 3003249645-2025-00034
• Device Sequence Number: 3825917
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: CEV525
• Device Lot Number: 03-07 SAV 03-2020
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2020
• 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 Age: 50 YR
• Patient Sex: Male