BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 6132879 · Received November 29, 2016

    Report

    Report Number
    2134070-2016-00087
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 8, 2016
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS GIVEN.

    Additional Manufacturer Narrative · 1

    THE CLIP APPLIER WAS RETURNED WITH ONLY A SINGLE CLIP REMAINING WHICH WAS PRESENT IN THE JAWS. THE DEVICE WAS FIRED AND THE SINGLE CLIP THAT WAS PRODUCED BEFORE THE LOCKING MECHANISM ENGAGED DISPLAYED THE PROPER PINCH AND ALIGNMENT. BASED ON THIS EVIDENCE THE ACCOUNT'S COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MISFIRED DURING A CASE. NO PATIENT INJURY OR CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION REQUEST RECEIVED IN A PHOTO OF THE MALFORMED CLIP IN A TEAR DROP SHAPE WITH DOUBLE CLIPS FORMED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783363 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1