BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR

    MDR report key: 3760651 · Received April 21, 2014

    Report

    Report Number
    1221934-2014-00146
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    October 23, 2013
    Report Date
    October 29, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K113545
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER CUSTOMER'S COMPLAINT, GENERATOR WAS SMOKING DURING A ROTATOR CUFF PROCEDURE, UNIT WAS EVALUATED AND THE RF BOARD WAS FOUND DAMAGED DUE TO A BLOWN CAPACITOR. SO THE DUAL RF BOARD WAS REPLACED TO CORRECT THE PROBLEM. MULTIPLE SCRATCHES ON UNIT FASCIA, TOP PLATE AND BASE PLATE; REPLACED THE TOP PLATE, BASE PLATE AND FASCIA. THE UNIT WAS MISSING 2 MOUNTING FEET AND DUST COVER; SO THEY WERE REPLACED. AS PER SERVICE MANUAL, THE KEYPAD MEMBRANE, MITEK BADGE, BOTH LEFT AND RIGHT GRAPHIC PANELS WERE REPLACED ALONG WITH THE FASCIA. ALSO, THE FAN BRACKET, 2 HEX NO8 SPACERS, 2 WASHERS ANTI LOSS AND 2 M3 X 60MM SCREWS WERE INSTALLED DUE TO THE REPLACEMENT OF THE DUAL RF BOARD. AN UPGRADE WAS PERFORMED PER SERVICE MANUAL. THIS COMPLAINT CAN BE CONFIRMED AND ATTRIBUTED TO MALFUNCTION OF THE DEVICE. AT THIS TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP, THE GENERATOR WAS SMOKING DURING A ROTATOR CUFF PROCEDURE. THE UNIT WAS SWAPPED OUT AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240672 MITEK VAPR VAPR GENERATORS GEI DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1