BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3983332 · Received July 2, 2014

    Report

    Report Number
    2134070-2014-00127
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETRIEVED FROM THE USER FACILITY AND IS CURRENTLY IN TRANSIT TO THE MANUFACTURER. A FOLLOW-UP REPORT WILL BE SENT AFTER DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SECOND AND THIRD CLIPS THAT WERE APPLIED TO A DUCT IN A GALLBLADDER CASE WERE MISFIRED. THE CLIPS CLAMPED DOWN IN MISALIGNMENT. THE ISSUE WAS NOTICED AND THE CLIPS REMOVED BEFORE THE DUCT WAS CUT. THERE WERE NO PATIENT INJURIES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387072 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1