BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3820837 · Received April 15, 2014

    Report

    Report Number
    2134070-2014-00070
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    PMA / PMN Number
    K050343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. UPON EVALUATION IT WAS SEEN UNDER MAGNIFICATION THAT THE BULK OF THE TISSUE PAD WAS COMPLETELY MISSING, BUT INSIDE THE JAW WHERE THE TISSUE PAD WOULD BE SEATED THE WHITE REMNANTS OF THE PAD WERE STILL VISIBLE. THE JAW WAS HEAVILY BLACKENED AND THE REMAINING PART OF THE PAD WAS MELTED. THE CLAMP ARM WAS ABLE TO FULLY OPEN AND CLOSE AS INTENDED. THE DEVICE PASSED ALL ELECTRICAL TESTING. NO LOT NUMBER WAS PROVIDED FOR THE DEVICE, SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR DISCREPANCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP CAME OFF THE DEVICE DURING A PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT THE PROCEDURE WAS A SLEEVE GASTRECTOMY. IT WAS THE TISSUE PAD THAT BROKE OFF, AND THE PAD WAS EASILY RETRIEVED. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230606 NA NLQ STERILMED, INC. ETHACE45E

    Patients

    Seq Age Sex Outcome Treatment
    1