BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4620346 · Received March 20, 2015

    Report

    Report Number
    9680837-2015-00025
    Event Type
    Malfunction
    Date Received
    March 20, 2015
    Report Date
    February 25, 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: CEV633-1A - BIPOLAR INSERT. CEV633-1A BOTELLA; QTY ¿(B)(4); MANUFACTURE DATE ¿ NOVEMBER 2014; LOT NUMBER ¿ 141104; 510K NUMBER - K993655. CEV649-5B - TUBE CEV649-5B DIA 5MM 310MM; QTY ¿ (B)(4); MANUFACTURE DATE ¿ NOVEMBER 2014; LOT NUMBER ¿ 141103; 510K NUMBER - K993655. (B)(4). THE FORCEPS WERE SHORT-CIRCUITED. AFTER DISASSEMBLY, IT APPEARED THAT THERE WAS IMPACT ON THE WIRE'S COATING/INSULATION, UNDER THE TUBE. THE ELECTRICAL INSULATION WAS COMPROMISED, BUT THE RISK FOR THE PATIENT OR USER WAS VERY LOW. THIS IS MOST LIKELY A RESULT OF A COATING/INSULATION DEFECT. THE COATING/INSULATION WAS DAMAGED. THE ELECTRICAL INSULATION WAS COMPROMISED. HOWEVER, CONSIDERING THE POSITION OF THE DAMAGE, THE RISK OF AN ELECTRICAL ARC IS LOW. THE MOST PROBABLE CAUSE IS IMPACT WITH ANOTHER INSTRUMENT DURING USE OR REPROCESSING. TWO TUBES WERE RETURNED FOR REPAIR. THE PRODUCT ANALYSIS INDICATES THAT THE DISTAL SCREW THREADS OF BOTH TUBES ARE BROKEN. THE FRAGMENTS WERE NOT RETURNED, BUT THIS PART IS ASSEMBLED INSIDE THE INSERT. THERE IS NO RISK OF FRAGMENT IN THE PATIENT. NO MANUFACTURING OR MATERIAL DEFECT WAS FOUND. HOWEVER, THERE WAS EVIDENCE OF IMPACT ONE OF THE TUBES AND THE ELECTRICAL INSULATION WAS COMPROMISED. THESE TUBES WERE MOST LIKELY DISASSEMBLED WITH EXCESSIVE FORCE DURING REPROCESSING. THE IMPACT ON ONE OF THE TUBES IS, IN ALL LIKELIHOOD, FROM IMPACT WITH ANOTHER INSTRUMENT. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    THE DEVICES (BIPOLAR FORCEPS, BIPOLAR INSERT, AND TUBE) WERE RETURNED FOR REPAIR. EVALUATION OF THE DEVICES INDICATES THAT THE ELECTRICAL INSULATION OF EACH DEVICE WAS COMPROMISED. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189183 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV133 141201

    Patients

    Seq Age Sex Outcome Treatment
    1