BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 6076652 · Received November 3, 2016

    Report

    Report Number
    2134070-2016-00080
    Event Type
    Malfunction
    Date Received
    November 3, 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 NOT ABLE TO BE REVIEWED AS NO LOT NUMBER WAS GIVEN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS FUNCTION TESTED AND FIRED UNTIL ALL REMAINING CLIPS WERE SPENT. THE DEVICE DISPLAYED NO DEFECT AND EVERY CLIP THAT WAS FIRED DISPLAYED THE PROPER ALIGNMENT AND PINCH. NO DEFECT WAS FOUND WITH THE PERFORMANCE OF THE DEVICE. 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 BY TWISTING STAPLES AND SCISSORING. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727260 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1