BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3976102 · Received August 4, 2014

    Report

    Report Number
    9680837-2014-00065
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: CEV6795B - TUBE CEV6795B DIA 5MM 310MM. LOT NUMBER 140202 - CEV634-1A - BIPOLAR INSERT CEV634-1A MOUIEL. LOT NUMBER 140207. (B)(4). PRODUCT EVALUATION: ANALYSIS FOUND THAT THE BLACK PLASTIC PART ON CEV669B IS BURNT AT THE CONNECTION LEVEL. 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). THE COATING DAMAGES ARE IN ALL LIKELIHOOD DUE TO A CLEANING WITH AN ABRASIVE MATERIAL. DEVICE FAILED ELECTRICAL TESTING. ANALYSIS FOUND NO FAULT WITH THE TUBE CEV6795B. ONE OF THE WIRES OF THE ELECTRODE ON CEV634-1A IS SLIGHTLY BENT OUT OF THE TUBE. THE INSERT CANNOT BE USED IN THIS CONDITION. THE INSERT PASSES THE ELECTRICAL TESTS. NO RISK FOR THE PATIENT OR THE USER. THE MOST PROBABLE CAUSE IS A DEFECT IN THE GLUING OF THE WIRES INSIDE THE TUBE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH A REQUEST ¿TO BE CHECKED¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT THE BLACK PLASTIC PART IS BURNT AT THE CONNECTION LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453276 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 140106

    Patients

    Seq Age Sex Outcome Treatment
    1