BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV2295A 3PK N5 FOR HOOK HANDLE

    MDR report key: 20452233 · Received October 15, 2024

    Report

    Report Number
    3003249645-2024-00047
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 14, 2024
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K210942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THREE (3) - 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) WERE RETURNED FOR EVALUATION. TWO (2) WERE USED DURING THE REPORTED EVENT AND THE THIRD WAS RETURNED FOR PREVENTATIVE EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE RETURNED HOOKS FOR HOOK HANDLE VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. THE COATING OF TWO HOOKS WERE DAMAGED; IT WAS MELTED. NO PROBLEM WAS IDENTIFIED ON THE THIRD HOOK. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT THIS DAMAGE WAS PROBABLY DUE TO THE USE OF TOO HIGH OF VOLTAGE OR A PROLONGED ACTIVATION OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON FIRST USE, THE BLUE COATING OF TWO (2) OF THE 3PK N5 HOOK FOR HOOK HANDLE (CEV2295A) MELTED DURING SURGERY, USING 35W ELECTROSURGICAL UNITS. IT WAS REPORTED THAT THE DEVICES WERE IN CONTACT WITH THE PATIENT. HOWEVER, NO PARTS FELL INTO THE SURGICAL SITE; NO INJURY OR SIGNIFICANT SURGICAL DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316657 HOOK CEV2295A 3PK N5 FOR HOOK HANDLE PFM16 GEI INTEGRA MICROFRANCE S.A.S. 7116669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DIA 5MM 350MM HOOK HANDLE (CEV229-1A).