BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3950763 · Received June 9, 2014

    Report

    Report Number
    2134070-2014-00118
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT AND WAS REPORTED TO BE DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS WERE MALFORMED, COMING OUT SIDEWAYS, SCISSORED AND NOT CLOSED PROPERLY WHEN THEY DID COME OUT OF THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS REPORTED TO BE DISCARDED BY THE USER FACILITY. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334342 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1