BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3813426 · Received March 31, 2014

    Report

    Report Number
    2134070-2014-00058
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 5, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH A CLIP IN THE JAW. THE JAW APPEARED TO BE IN ALIGNMENT, AND THE PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVALUATION, THE SIX REMAINING CLIPS WERE FIRED FROM THE DEVICE. THE CLIP THAT WAS IN THE JAW UPON RETURN WAS PRODUCED WITH PROPER PINCH , BUT WAS SCISSORED. THE FIVE OTHER REMAINING CLIPS WERE CYCLED, FED, AND PRODUCED WITH PROPER PINCH AND ALIGNMENT. AFTER THE LAST CLIP WAS FIRED THE LOCKING MECHANISM ENGAGED AS INTENDED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRICECTOMY, CLIP "SCISSORED" CAUSING NON-SECURE STAPLE LINE. ANOTHER DEVICE WAS USED TO SECURE THE STAPLE LINE INSTEAD. THERE WAS NO PT INJURY. A PHOTOGRAPH OF A SCISSORED CLIP ON PT TISSUE WAS INCLUDED WITH THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190061 NA NMJ STERILMED, INC. ETHER320 1733362

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR