BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3020571 · Received March 20, 2013

    Report

    Report Number
    2027111-2013-00080
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 20, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY - "THE CLIP APPLIER WAS INSERTED BY DR (B)(6) INTO THE PT'S ABDOMEN THROUGH THE 12MM SUBXIPHOID PORT. DR (B)(6) DEPLOYED FIVE CLIPS. CLIP NUMBERS FOUR AND FIVE WERE THEN REMOVED FROM THE PT'S ABDOMEN BY DR (B)(6) AND DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116716 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1171480

    Patients

    Seq Age Sex Outcome Treatment
    1