MAUDE Adverse Event Report: Integra MicroFrance S.A.S. HOOK CEV2295A 3PK N5 FOR HOOK HANDLE; Microfrance Instruments

Catalog Number	CEV2295A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the hook cev2295a 3pk n5 for hook handle (cev2295a) had a melted sheath.There was no impact to the patient; therefore, no injury, death, or surgical delay was reported.
Additional Manufacturer Narrative
The hook cev2295a 3pk n5 for hook handle (cev2295a) was returned for evaluation: failure analysis: investigation findings showed that the blue coating melted at the end of the hook, revealing the metal of the hook.Root cause analysis: the blue coating melted, probably due to high voltage applied during use or contact with another instrument causing an electrical arc.This issue is being addressed in an ongoing corrective and preventive action (capa).

• Brand Name: HOOK CEV2295A 3PK N5 FOR HOOK HANDLE
• Common Device Name: Microfrance Instruments
• 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 ; +1(609)936-2319
• MDR Report Key: 50197699
• Report Number: 3003249645-2026-00033
• Device Sequence Number: 21424145
• Product Code: GEI
• UDI-Device Identifier: 10381780092551
• UDI-Public: 10381780092551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/10/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOOK HANDLE CEV229-1A DIA 5MM 350MM (CEV229-1A).
• Patient Sex: Unknown