BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2982640 · Received February 25, 2013

    Report

    Report Number
    2027111-2013-00063
    Date Received
    February 25, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LAP APPY - "CLIPS FIRED WERE LOOSE AND FALLING OFF DUCT AND ARTERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80029 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1172562

    Patients

    Seq Age Sex Outcome Treatment
    1 DIRECT DRIVER DISPOSABLE CLIP APPLIER: 10 MM 3/BOX| CA090, LOT #1183672