BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR PREMIERE 90

    MDR report key: 2052141 · Received March 23, 2011

    Report

    Report Number
    2052141
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    DEPUY MITEK INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DEPUY MITEK VAPR PREMIERE 90 ELECTRODE (CATALOG NUMBER 227204) USED DURING SHOULDER ARTHROSCOPY. SURGEON REPORTED IT WAS NOT WORKING AS USUAL; WAS NOT HEATING UP. INCREASED THE SETTING, BUT NO IMPROVEMENT OCCURRED. OPENED SECOND ONE WITH SAME LOT NUMBER AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR PREMIERE 90 ELECTRODE GEI DEPUY MITEK INC * 1102035

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR