BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4180962 · Received October 17, 2014

    Report

    Report Number
    9680837-2014-00087
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 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

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: ALL CONCOMITANT DEVICES MANUFACTURED BY: XOMED (B)(4) MFG (B)(4), 3160 FR - CEV6795B - TUBE; CEV6795B, DIA 5MM 310MM, LOT 08-06, MANUFACTURED DATE AUGUST 2006; CEV634-1A - BIPOLAR INSERT; CEV634-1A MOUIEL, LOT 09-06, MANUFACTURED DATE SEPTEMBER 2006; CP393-2 - CABLE CP393-2 4.5M BIPOLAR VALLEYLAB, LOT UNKNOWN, MANUFACTURED DATE UNKNOWN. (B)(4). PRODUCT EVALUATION: ANALYSIS ON CEV669B FOUND THAT THE BLACK PLASTIC PART IS BURNT AT THE CONNECTION. DEVICE FAILED ELECTRICAL TESTS. 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. ANALYSIS ON CEV6795B FOUND THAT THERE WAS NO HIGHLIGHTED ISSUE; THE INSTRUMENT IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS. DEVICE PASSED ELECTRICAL TESTS. ANALYSIS ON CEV634-1A FOUND THAT THERE WAS NO HIGHLIGHTED ISSUE; THE INSTRUMENT IS COMPLIANT WITH THE MANUFACTURING SPECIFICATIONS. DEVICE PASSED ELECTRICAL TESTS. ANALYSIS ON CP393-2 FOUND THAT THE CONNECTOR OF THE CABLE IN CONTACT WITH THE HANDLE IS BURNT. ELECTRICAL CONTINUITY TEST OK. THE BURN OF CONNECTOR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ¿DOES NOT WORK ANYMORE¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT THE BLACK PLASTIC PART IS BURNT AT THE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662570 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 09-06

    Patients

    Seq Age Sex Outcome Treatment
    1