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	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The forceps cev525 fenestrated 20mm jawz (cev525) was not returned for evaluation: failure analysis: product or objective evidence was not returned, so the evaluation could not be performed.Therefore, an investigation into the cause could not be performed.The customer sent the instrument to another service provider for repair.Root cause analysis: product or objective evidence was not returned, so the evaluation could not be performed.Therefore, an investigation into the cause was unable to be performed.The customer sent the instrument to another service provider for repair.Integra microfrance (imf) recommends repairs within its factory and cannot guarantee the services provided by an external service provider.It is impossible to determine the root cause.
Event or Problem Description
A facility reported that two pieces of the forceps cev525 fenestrated 20mm jawz (cev525) sheath became loose and fell into the patient's abdomen.It is unknown if there was a patient's injury, death, or surgical delays.

• 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: 23720825
• Report Number: 3003249645-2025-00055
• Device Sequence Number: 8532032
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: 091297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/04/2025
• 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