BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2980417 · Received February 22, 2013

    Report

    Report Number
    2134070-2013-00035
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    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 EVAL, IT WAS NOTED THAT THE DEVICE FIRED CLIPS WITH EXCESSIVE FORCE AND SPEED. HOWEVER, THE CLIPS RELEASED HAD PROPER PINCH AND ALIGNMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AN NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY THE DEVICE CUT A VESSEL. ANOTHER SURGEON WAS CALLED IN FOR ASSISTANCE. ANOTHER CLIP WAS USED TO CLIP THE VESSEL AND COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77293 NA NONE NMJ STERILMED, INC. ETHMCM20

    Patients

    Seq Age Sex Outcome Treatment
    1