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	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 3pk n5 hook for hook handle (cev2295a) melted during a procedure.Generator assessment was performed by a 3rd party maintenance company and named supplier.The "supplier's assessment appears to be compliant." the issue identified was "lack of knowledge of electrosurgery settings, which may have caused an over voltage beyond the hook's tolerance".It was reported that there was risk of burn and risk of plastic particles falling into the patient; however, no patient injury, death or surgical delay was 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.
Additional Manufacturer Narrative
The 3pk n5 hook for hook handle (cev2295a) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation of the n5 hook for hook handle (cev2295a) verified the problem statement as confirmed.The blue coating was melted on the tip side.Root cause analysis: it was determined that the reported problem was likely due to the use of voltage that was too high or a prolonged activation of the device.A corrective and preventative action is being processed regarding this problem and to confirm the root cause.
Additional Manufacturer Narrative
Update fields: g3, g6, h2, h6 (investigation findings), h11.H6 (investigation findings), was changed from c23 to c11.

• 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 08536 ; 6099362319
• MDR Report Key: 22059949
• Report Number: 3003249645-2025-00019
• Device Sequence Number: 8478186
• 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,Followup
• Report Date (Section B): 08/01/2025

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: CEV2295A
• Device Lot Number: UNKNOWN
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/31/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/30/2025; 08/01/2025
• 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