BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4547153 · Received February 25, 2015

    Report

    Report Number
    9680837-2015-00021
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Report Date
    February 2, 2015
    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

    CONCOMITANT MEDICAL PRODUCTS. CEV669B: HANDLE DIA 5MM ANG BIPOLAR, MANUFACTURE DATE ¿ APRIL 2014, LOT ¿ 140404, 510K# - (B)(4). CEV6795B: TUBE DIA 5MM 310MM, MANUFACTURE DATE - APRIL 2014, LOT ¿ 140404, 510K# - (B)(4). (B)(4) CEV634-1A: THE PRODUCT ANALYSIS INDICATES THE WIRES SLIGHTLY CAME OUT OF THE TUBE. THE INSERT WAS SHORT CIRCUITED AND FAILED ELECTRICAL TESTS. HOWEVER, IT IS NOT DANGEROUS FOR THE PATIENT OR THE USER. THE BIPOLAR PINS ARE BENT. THE WIRES PROBABLY CAME OUT OF THE TUBE DUE TO EXCESSIVE EFFORT ON THE PINS DURING ASSEMBLY OF THE INSERT ONTO A HANDLE. THE SHORT CIRCUIT IS MOST LIKELY A RESULT OF DAMAGE TO THE WIRE COATING/INSULATION DURING THEIR DISPLACEMENT. CEV669B: THE PRODUCT ANALYSIS INDICATES THAT THE BLACK PLASTIC PART WAS BURNT AT THE CONNECTION. THE BURNT PLASTIC PART IS THE RESULT OF AN ELECTRICAL ARC. THE ELECTRICAL ARC IS MOST LIKELY DUE TO THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE (CABLE NOT DRIED, BLOOD, AND/OR TISSUE). THE PRESENCE OF HUMIDITY MAY BE THE RESULT OF INADEQUATE CLEANING OR DRYING OF THE INSTRUMENT. CEV6795B: THERE WAS NO HIGHLIGHTED ISSUE FOUND. THE TUBE MEETS MANUFACTURING SPECIFICATIONS. RESULT: STRESS PROBLEM. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    THE BIPOLAR INSERT, HANDLE, AND TUBE WERE RETURNED FOR REPAIR. THE INTEGRITY OF THE BIPOLAR INSERT INSULATION HAD BEEN COMPROMISED AND THE HANDLE WAS BURNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132447 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 140415

    Patients

    Seq Age Sex Outcome Treatment
    1