BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 23127758 · Received September 23, 2025

    Report

    Report Number
    3003249645-2025-00039
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 15, 2025
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: PRODUCT OR OBJECTIVE EVIDENCE WAS RETURNED, AND THE EVALUATION VERIFIED THAT THE PROBLEM STATEMENT IS CONFIRMED. THE BLUE COATING IS MELTED ON THE TIP SIDE OF THE HOOK. ROOT CAUSE ANALYSIS: THIS IS PROBABLY DUE TO THE USE OF TOO HIGH A VOLTAGE OR A PROLONGED ACTIVATION OF THE DEVICE. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA-00294) IS BEING PROCESSED REGARDING THIS PROBLEM, AND TO CONFIRM THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOOK CEV2295A 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED IN THE PATIENT'S PELVIS DURING A PROCEDURE. IT IS UNKNOWN WHETHER THERE WERE ANY CLINICAL CONSEQUENCES, SUCH AS INJURY, DEATH, SURGICAL DELAY, OR WHETHER ADDITIONAL PROCEDURES WERE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196873 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown