BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3063657 · Received April 12, 2013

    Report

    Report Number
    2134070-2013-00089
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVAL, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE UPON ACTIVATION OF THE DEVICE, THE LOADS MISFIRED/WERE NOT ALIGNED CORRECTLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY. THERE WAS NO PT INJURY. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS PROVIDED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159434 NA NMJ STERILMED, INC. ETHER420

    Patients

    Seq Age Sex Outcome Treatment
    1