BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/ BOX

    MDR report key: 2426148 · Received January 19, 2012

    Report

    Report Number
    2027111-2012-00006
    Event Type
    Other
    Date Received
    January 19, 2012
    Date of Event
    October 27, 2011
    Report Date
    January 19, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAP CHOLE ON UPPER GI/GEN SURG - "THE CLIP APPLIER WAS BEING USED IN THIS CASE AS THERE WAS A LARGE AMOUNT OF OOZE AND BLEEDING. THE CLIP APPLIER DISPENSED 2-3 CLIPS AND THEN JAMMED, MAKING IT DIFFICULT TO CONTROL BLEEDING AND CAUSING DAMAGE TO THE BLEEDING AREA. THE CLIP APPLIER WAS REMOVED FROM THE SET UP AND RINSED OF THE MAJORITY OF THE BLOOD ON THE INSTRUMENT AND PLACED IN A BAG." PATIENT STATUS: - UNKNOWN, RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/ BOX NONE GDO APPLIED MEDICAL CA090 1150571

    Patients

    Seq Age Sex Outcome Treatment
    1 Other