BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS CEV134 BIPOLAR 350MM MOUIEL [MXI/XOM]

    MDR report key: 3609854 · Received February 5, 2014

    Report

    Report Number
    9680837-2014-00008
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 14, 2014
    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

    (1) FORCEPS BIPOLAR 350MM MOUIEL (CEV134); LOT: 130702; MANUFACTURED: JULY 2013; RETURNED TO MEDTRONIC: (B)(4) 2014 (B)(4). BOTH DEVICES WERE RETURNED TO MEDTRONIC¿S INTERNATIONAL MANUFACTURING SITE FOR EVALUATION AND REPAIR. THE INVESTIGATION REPORT FOUND EACH DEVICE SHOWED EVIDENCE OF HEAT DAMAGE (BURN/CHARRED/BLACKENED/ELECTRICAL ARC)...THE BLACK PLASTIC PART OF THE INSTRUMENT WAS FOUND BURNT AT THE CONNECTION AND IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC PROBABLY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED / BLOOD / TISSUES). THE DEVICES ALSO FAILED ELECTRICAL TESTS. BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 350MM MOUIEL BIPOLAR FORCEP WAS SENT IN WITH THE REQUEST TO BE REPAIRED DUE TO ¿CRACKLES¿. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74863 FORCEPS CEV134 BIPOLAR 350MM MOUIEL [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV134 121101

    Patients

    Seq Age Sex Outcome Treatment
    1