BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4583022 · Received March 9, 2015

    Report

    Report Number
    9680837-2015-00022
    Event Type
    Malfunction
    Date Received
    March 9, 2015
    Report Date
    February 12, 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 PRODUCTS. CEV669B ¿ HANDLE DIA 5MM ANG BIPOLAR; MANUFACTURING DATE ¿ SEPTEMBER 2006; LOT ¿ 09-06; 510K ¿ K993655. CEV6795B ¿ TUBE DIA 5MM 310MM; MANUFACTURE DATE ¿ FEBRUARY 2004; LOT ¿ 02-04; 510K ¿ K993655. (B)(4). CEV634-1A; THE PRODUCT ANALYSIS INDICATES THAT THE INSERT HAD SHORT-CIRCUITED, COULD NOT COAGULATE, AND FAILED ELECTRICAL TESTS. THE ELECTRICAL INTEGRITY WAS COMPROMISED, BUT THERE WAS VERY LOW RISK FOR THE PATIENT OR THE USER. THE MOST PROBABLE CAUSE IS A DEFECT DURING THE COATING PROCESS. CEV669B: THERE WAS NO FAULT FOUND WITH THE HANDLE. CEV6795B: THERE WAS NO FAULT FOUND WITH THE TUBE. CONCLUSION CODE: MANUFACTURING DEFICIENCY C91881. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASSEMBLED DEVICE (BIPOLAR INSERT, HANDLE, AND TUBE), WOULD NOT COAGULATE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162014 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV634-1A 141012

    Patients

    Seq Age Sex Outcome Treatment
    1