MAUDE Adverse Event Report: INTEGRA MICROFRANCE S.A.S. HOOK HANDLE CEV229B DIA5MM 380MM; PFM16

Catalog Number	CEV229B
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
Event or Problem Description
This is 2 of 2 reports for the 1st device reportedly used during this event.This report is linked to mfg# 3003249645-2025-00051.It was reported that during a laparoscopic procedure, the surgeon noticed that the hook handle cev229b dia5mm 380mm (cev229b) 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.
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
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.Device history record (dhr): the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were identified.Failure analysis: the hook handle cev229b dia5mm 380mm is not affected by the reported complaint.This hook handle has been repaired on several occasions by an external service provider, (b)(6).Root cause analysis: this hook handle has undergone multiple repairs by the external service provider, petel.Integra microfrance (imf) recommends that repairs be conducted within its own facility and cannot guarantee the quality or outcomes of services performed by external providers.

• Brand Name: HOOK HANDLE CEV229B DIA5MM 380MM
• 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: 23562137
• Report Number: 3003249645-2025-00052
• Device Sequence Number: 18599297
• Product Code: GEI
• UDI-Device Identifier: 10381780092568
• UDI-Public: 10381780092568
• 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): 12/30/2025

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: CEV229B
• Device Lot Number: 6764638
• 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: 12/09/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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