BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3042949 · Received April 4, 2013

    Report

    Report Number
    2134070-2013-00079
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Report Date
    March 14, 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

    THE DEVICE WAS NOT RETURNED TO THE MFR AND WAS REPORTED TO BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MISFIRED. IT WAS LATER REPORTED THAT THE EVENT OCCURRED DURING A NEPHRECTOMY. CLIPS CAME OUT OF THE DEVICE "ANGLED" AND DAMAGED A VESSEL. THE VESSEL WAS REPAIRED USING ANOTHER CLIP. IT WAS UNCLEAR WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO OTHER CHANGE TO THE PROCEDURE. THE DEVICE WAS REPORTED TO BE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138576 NA NMJ STERILMED, INC. ETHMCM20

    Patients

    Seq Age Sex Outcome Treatment
    1