MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA; PFM16

Catalog Number	CEV133
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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
A facility reported that during a procedure, and the first very first time they used the pilers, they noticed that the forceps cev133 bipolar 350mm lrg botella (cev133) were difficult to close, "they are particularly stiff." it was reported that replacement units were used to complete the surgery.The product was not in contact with the patient; thus, no injury or death was reported.However, there was a 30-minute increase in surgical time to find an alternative suitable instrument.
Additional Manufacturer Narrative
The forceps cev133 bipolar 350mm lrg botella (cev133) was not returned for evaluation.The device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.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 potential root cause of the problem may be a lack of lubrication or a trimming issue, as the pin was too dull.It could be confirmed with an investigation of the instrument.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected fields: h6: (investigation findings 1) and (investigation conclusions 1).
Event or Problem Description
N/a.

• Brand Name: FORCEPS CEV133 BIPOLAR 350MM LRG BOTELLA
• 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: 23408114
• Report Number: 3003249645-2025-00048
• Device Sequence Number: 13016486
• Product Code: GEI
• UDI-Device Identifier: 10381780091806
• UDI-Public: 10381780091806
• Combination Product (Y/N): N
• PMA/510(K) Number: K210942
• 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,Followup,Followup
• Report Date (Section B): 02/02/2026

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: CEV133
• Device Lot Number: 7534141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 01/14/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/11/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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