BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4625807 · Received March 24, 2015

    Report

    Report Number
    9680837-2015-00027
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 27, 2015
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS. CEV2295A - HOOK 3PK N5 FOR HOOK HANDLE; MANUFACTURE DATE ¿ NO INFORMATION; LOT NUMBER ¿ NO INFORMATION; 510K NUMBER - K993655. (B)(4). EVALUATION OF THE DEVICE INDICATES THAT THERE WAS NO HIGHLIGHTED ISSUE. THE HANDLE, AND ESPECIALLY THE DISTAL SCREW THREAD, IS WITHIN MANUFACTURING SPECIFICATIONS. EVALUATION OF THE DEVICE INDICATES THAT THE COATING/INSULATION IS SLIGHTLY DAMAGED. THE SCREW THREAD IS WITHIN MANUFACTURING SPECIFICATIONS. THE DAMAGES ON THE COATING/INSULATION ARE MOST LIKELY DUE TO THE SUCCESSIVE USES AND REPROCESSING. THE EVENT MOST LIKELY OCCURRED AS A RESULT OF INCOMPLETE ATTACHMENT OF THE HOOK ONTO THE HANDLE. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOPERATIVE, THE HOOK FELL INTO THE PATIENT AND WAS RECOVERED. THE CUSTOMER ALSO REQUESTED THAT THE SCREW THREAD BE EVALUATED AND/OR REPAIRED. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197135 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV82291 110601

    Patients

    Seq Age Sex Outcome Treatment
    1