BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 23631387 · Received November 24, 2025

    Report

    Report Number
    3003249645-2025-00054
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    UDI-DI
    10381780092551
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE CUSTOMER RETURNED SIX HOOKS; ONE OF THEM WAS NOT COATED AT INTEGRA MICROFRANCE (IMF), THE LIGHTEST BLUE. THE BLUE COATING HAD MELTED ON THE ENDS OF THE HOOKS. SOME COATINGS WERE BLISTERED; ANOTHER HAD A BLACK DEPOSIT. ANOTHER HAS BEEN RUBBED WITH AN ABRASIVE MATERIAL, PRESUMABLY DURING CLEANING. ROOT CAUSE ANALYSIS: THE BLISTERING IS PROBABLY DUE TO THE USE OF TOO HIGH A VOLTAGE OR A PROLONGED ACTIVATION OF THE DEVICE. THE HOOK WHOSE COATING WAS BLACKENED WAS MOST LIKELY IN CONTACT WITH ANOTHER INSTRUMENT. THE COATING WAS SCRATCHED BY THE USE OF AN OVERLY ABRASIVE MATERIAL DURING THE CLEANING. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN RAISED TO INVESTIGATE THIS ISSUE AND IS PENDING CORRECTIVE ACTION.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED AT ITS ENDS. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT, INJURY, DEATH, OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491246 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S. 10381780092551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown