BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2872045 · Received December 11, 2012

    Report

    Report Number
    2134070-2012-00313
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED WITH PROPER PINCH AND ALIGNMENT. IN ADDITION THE DEVICE LOCKED OUT 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 MIDWAY THROUGH A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE PRODUCED CLIPS THAT CROSSED AND DID NOT CLOSE. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. IT WAS LATER REPORTED THAT NO CLIPS HAD BEEN SUCCESSFULLY FIRED PRIOR TO THE CROSSED CLIPS. THERE WAS NO UNUSUAL NOISES OR RESISTANCE FELT. THE CROSSED CLIPS WAS RETRIEVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR