BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4395048 · Received January 8, 2015

    Report

    Report Number
    9680837-2015-00005
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Report Date
    December 15, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS IN THIS REPORT ARE THE RESULT OF INFORMATION NOT PROVIDED BY THE INITIAL REPORTER OR USER FACILITY. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: CEV636-1A BIPOLAR INSERT, LOT 140803; A CEV669B BIPOLAR HANDLE, LOT 140105; A CEV669B BIPOLAR HANDLE, LOT 140102; A CEV6795B TUBE, LOT 140901. (B)(4). THE INSTRUMENTS WERE RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. EVALUATION OF THE HANDLES (PART # CEV669B) WITH LOTS 140906 AND 140102 FOUND BURNT BLACK PLASTIC PARTS AT THE CONNECTION. THE HANDLE (PART # CEV669B) WITH THE LOT 140105 CAME BACK DISASSEMBLED. THE CENTRAL PART IS MISSING. THE BURN OF THE PLASTIC PART 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). IT CAN COME FROM A DEFECT OF CLEANING OR OF DRYING OF THE INSTRUMENT. THE HANDLE (CEV669B) WITH THE LOT 140105 HAS PROBABLY BEEN DISASSEMBLED BY THE CUSTOMER DURING ITS REPROCESSING." EVALUATION FOUND THAT IN THE BIPOLAR INSERT (PART #CEV636-1A) ONE OF THE WIRES OF THE ELECTRODE IS UNGLUED FROM THE TUBE. THE INSERT CANNOT BE USED IN THIS CONDITION. THE MOST PROBABLE CAUSE OF THE DISPLACEMENT OF THE WIRE IN THE TUBE IS A GLUING DEFECT. EVALUATION OF TUBE (PART # CEV6795B) FOUND NO HIGHLIGHTED ISSUE; THE TUBE IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    MULTIPLE INSTRUMENTS WERE RETURNED FOR EVALUATION AND REPAIR. THE ANALYST REPORTED THAT DURING EVALUATION OF TWO BIPOLAR HANDLES ¿THE HANDLES WITH THE LOTS 140906 AND 140102 HAVE BURNT BLACK PLASTIC PARTS AT THE CONNECTION.¿ THERE WAS NO REPORT OF USER/PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17077 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 140906

    Patients

    Seq Age Sex Outcome Treatment
    1