BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR FORCEPS MCEN54 120MM DESSI [MXI]

    MDR report key: 3489447 · Received November 26, 2013

    Report

    Report Number
    9680837-2013-00499
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Report Date
    November 4, 2013
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: CABLE, CP393 4.5M BIPOLAR, LOT NUMBER AND MANUFACTURE DATE UNKNOWN. GEI, K993655. (B)(4). QUALITY ENGINEER REVIEWED THE DEVICES RETURNED. FORCEPS - FOUND THE FORCEPS DOES NOT COAGULATE AND THE DISTAL END INSULATION IS STRONGLY DAMAGED. THE ELECTRODE IS ON SHORT CIRCUIT. ALSO, THE HANDLE SCREW IS SLIGHTLY LOOSE. THE COATING HAS PROBABLY BEEN DAMAGED BY AN EXCESSIVE ABRASION OR FRICTION DURING THE USE OR THE REPROCESSING STEPS. THESE DAMAGES SHOULD HAVE BEEN NOTED BEFORE THE MALFUNCTION HAPPENED DURING THE INSPECTION BEFORE USE RECOMMENDED BY OUR IFU. THE DEVICE FAILED THE ELECTRICAL TESTS. CABLE ¿ NO EXTERNAL DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE FORCEPS WERE BEING RETURNED FOR REPAIR AS IT NEEDED TO BE REINSULATED ON THE TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616083 BIPOLAR FORCEPS MCEN54 120MM DESSI [MXI] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG MCEN54 201005MF2

    Patients

    Seq Age Sex Outcome Treatment
    1