BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3868006 · Received May 9, 2014

    Report

    Report Number
    2134070-2014-00099
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE JAWS APPEARED TO BE IN ALIGNMENT AND THE CLIP RETAINER AND PUSH FORK WERE IN POSITION. UPON EVALUATION, THE REMAINING CLIPS WERE CYCLED, FED AND PRODUCED WITH PROPER PINCH AND ALIGNMENT. THE DEVICE HAD BEEN SENT OUT WITH 17 CLIPS AND WAS RETURNED WITH 16 CLIPS IN THE SHAFT AND ONE IN THE JAW. NO CLIPS HAD BEEN USED. THE INSTRUCTIONS FOR USE STATE "PRIOR TO EACH CLIP APPLICATION, INSPECT THE JAW TIPS TO ENSURE THE CLIP IS FULLY ADVANCED TO THE END OF THE JAWS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS "SHREDDING VEIN." ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282262 NA NMJ STERILMED, INC. ETHMCM20 1734102

    Patients

    Seq Age Sex Outcome Treatment
    1