BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE, REPROCESSED

    MDR report key: 6132759 · Received November 29, 2016

    Report

    Report Number
    2134070-2016-00086
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FIRED UNTIL ALL REMAINING CLIPS WERE SPENT. THE DEVICE PRODUCED 3 CLIPS OF PROPER PINCH AND ALIGNMENT. NO DEFECT WAS DETECTED 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 DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIP WAS CROSSING ITSELF. IT WAS NOTED THAT ONE SIDE APPEARED LONGER THAN THE OTHER AND NOT CLOSING COMPLETELY. THERE WAS NO HARM OR CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783631 CLIP, IMPLANTABLE, REPROCESSED NMJ STERILMED, INC. ETHER320 1938416

    Patients

    Seq Age Sex Outcome Treatment
    1