MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; PFM16

Catalog Number	CEV2295A
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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
This is 1 of 2 reports for the 1st device reportedly used during this event.This report is linked to mfg number 3003249645-2025-00052.It was reported that during a laparoscopic procedure, the surgeon noticed that the hook cev2295a 3pk n5 for hook handle (cev2295a) hook melted, with blue traces on the image.The debris was removed and washed.There was no impact on the patient; thus, no injuries or surgical delays were reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.Corrected field: short description ¿ updated from 1/2 to 1/4 to reflect the number of products returned.The hook cev2295a 3pk n5 for hook handle (cev2295a) was returned for evaluation.The device history record (dhr): unable to review the applicable dhr as the batch number was unavailable failure analysis: the investigation identified that the blue coating at the end of the hook had melted.Root cause analysis: the initial assessment confirmed an alteration of the blue coating at the tip of the hook.This degradation may impact the performance of the device.At this time, no patient harm has been reported.Preliminary analysis indicates that blister formation and coating degradation may be associated with specific conditions of use, such as high voltage or prolonged activation of the device.These potential contributing factors are currently under investigation.Internal testing performed under the device¿s intended use conditions did not reproduce the melting phenomenon.To further assess potential contributing conditions, additional testing is being planned.A corrective and preventive action (capa) has been initiated to identify the root cause, evaluate associated risks, and define appropriate actions as necessary.The effectiveness of any implemented actions will be verified in accordance with the quality management system.

• Brand Name: HOOK CEV2295A 3PK N5 FOR HOOK HANDLE
• 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: 23557889
• Report Number: 3003249645-2025-00051
• Device Sequence Number: 13290509
• Product Code: GEI
• UDI-Device Identifier: 10381780092551
• UDI-Public: 10381780092551
• 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
• Report Date (Section B): 01/08/2026

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: CEV2295A
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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