BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3030447 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00113
    Date Received
    March 26, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    LAPAROSCOPIC APPENDECTOMY: "FROM THE 4TH CLIP, THE SURGEON FOUND THE CLIPS WERE UNABLE TO BE CLOSED COMPLETELY. HE TOOK OUT THE CLIP FROM THE PATIENT AND FIRED A FEW CLIPS FOR VERIFICATION, BUT STILL ONLY THE DISTAL END OF THE CLIPS WERE CLOSING WHILE THE REST WERE OPEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123317 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1156718

    Patients

    Seq Age Sex Outcome Treatment
    1