BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 6099052 · Received November 14, 2016

    Report

    Report Number
    2134070-2016-00082
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 8, 2016
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED EMPTY AND AS SUCH COULD NOT BE FUNCTION TESTED. NO VISUAL DEFECTS WERE NOTED IN THE ALIGNMENT OF THE JAWS. WITHOUT BEING ABLE TO FIRE A CLIP FROM THE COMPLAINT DEVICE THE ACCOUNT'S COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIP APPLIERS MISFIRED, RESULTING IN A TWISTED/SCISSORING OF THE CLIP. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750803 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320 1921261

    Patients

    Seq Age Sex Outcome Treatment
    1