BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3032812 · Received March 25, 2013

    Report

    Report Number
    2027111-2013-00086
    Date Received
    March 25, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 22, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST REC'D THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVAL. A F/U REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS 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

    LAP CHOLE - "NOT CLIPPING CORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121545 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1182943

    Patients

    Seq Age Sex Outcome Treatment
    1