BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 16396432 · Received February 17, 2023

    Report

    Report Number
    3003249645-2023-00006
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    October 19, 2021
    Report Date
    February 17, 2023
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 3PK N5 FOR HOOK HANDLE (CEV2295A) WAS RETURNED AND EVALUATION VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE COATING WAS MELTED NEAR THE HOOK. IT WAS DETERMINED THAT THE EVENT WAS PROBABLY DUE TO THE USE OF VOLTAGE THAT WAS OVER SPECIFICATION OR A PROLONGED ACTIVATION OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU), INSTRUCTS THE USER ON SAFETY AND WARNING POINTS TO FOLLOW WHEN USING AN ELECTROSURGICAL MONOPOLAR, IN ADDITION TO THE MAXIMAL ASSIGNED OUTPUT VOLTAGE TO USE.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS AND IS RELATED TO MFG: 3003249645-2023-00007: IT WAS REPORTED THAT THE HOOK OF THE 3PK N5 FOR HOOK HANDLE (CEV2295A) MELTED DURING SURGERY. THE POWER OF THE GENERATOR IS UNKNOWN. THERE WAS NO CONSEQUENCE TO THE PATIENT AND NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162539 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male