BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4448313 · Received January 23, 2015

    Report

    Report Number
    9680837-2015-00013
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 26, 2014
    Report Date
    December 30, 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

    365MM JOHANN FENESTRATED FORCEPS (CEV405); LOT: 140501; MANUFACTURED: MAY 2014; RETURNED TO MEDTRONIC: (B)(4) 2014; 510K: K993655 (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, A TOTAL OF 2 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): CEV405/LOT 100701 (QUANTITY 1) ¿ THE FORCEPS HAVE MULTIPLE IMPACTS ON THE INSULATION, FAILED ELECTRICAL TESTS AND THE INSULATION INTEGRITY IS COMPROMISED. THE MOST PROBABLE CAUSE IS DAMAGE DURING PRE-OPERATION STEPS. CEV405/LOT 140501 (QUANTITY 1) ¿ THE FORCEPS HAVE MULTIPLE IMPACTS ON THE INSULATION, FAILED ELECTRICAL TESTS AND THE INSULATION INTEGRITY IS COMPROMISED. AS A LARGE SCRATCH IN THE INSULATION CAN BE OBSERVED ON THE DISTAL END OF THE INSTRUMENT. THE DAMAGES ON THE INSULATION ARE PROBABLY DUE TO AN ABNORMAL USE WITH SOME SHOCKS DURING USE OR REPROCESSING. RESULT: MECHANICAL SHOCK PROBLEM (B)(4) BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    TWO 365MM JOHANN FENESTRATED FORCEPS WERE RETURNED TO MEDTRONIC AND UPON EVALUATION, THE ELECTRICAL INSULATION WAS COMPROMISED. THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55341 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV405 100701

    Patients

    Seq Age Sex Outcome Treatment
    1