BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3952969 · Received May 20, 2014

    Report

    Report Number
    2134070-2014-00101
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K012598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION, THE DEVICE JAWS WERE ABLE TO FULLY OPEN AND CLOSE, AND THE TRIGGER, SWITCHES AND LEVERS OPERATED AS INTENDED. THE BLADE WAS ABLE TO ACTUATE AND RELEASE FREELY. THE DEVICE WAS THEN ELECTRICALLY TESTED AND PASSED CONTINUITY, ISOLATION AND INSULATION TESTING. WHEN THE DEVICE WAS CONNECTED TO A GENERATOR, AN ERROR MESSAGE WAS DISPLAYED INDICATING THE COAGULATION WAS NOT COMPLETED PRIOR TO ANY PRESSURE BEING PLACED ON THE SWITCH. MANIPULATING THE SWITCH AND APPLYING FIRM PRESSURE ALLOWING THE DEVICE TO COMPLETE A FULL CYCLE AFTER THE DEVICE DISPLAYED ANOTHER ERROR MESSAGE. FURTHER INVESTIGATION OF THE DEVICE DETERMINED THAT WHEN CONNECTED TO THE GENERATOR BY ITSELF, AN ERROR CODE WAS IMMEDIATELY DISPLAYED WITH NO ENERGY GOING TO THE TIP. HOWEVER, IF PRIOR TO BEING PLUGGED INTO THE GENERATOR THE JAWS WERE FIRST CLAMPED DOWN ON TESTING MATERIAL AND THEN DEVICE WAS PLUGGED IN, THE TIP ACTIVATED WITHOUT THE TRIGGER BUTTON BEING PUSHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT WORK WHEN PLUGGED IN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THIS REPORT IS BEING FILED FOR THE FINDINGS UPON INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299296 NA NUJ STERILMED, INC. VALLS1020 1713701

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR