BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DEVICE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3181637 · Received June 14, 2013

    Report

    Report Number
    2027111-2013-00224
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 10, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVAL BUT LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56 IF WE OBTAIN ADDITIONAL 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

    GASTRIC BYPASS - "CLIPS ARE NOT CLOSING WHEN TRIGGERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271895 DIRECT DEVICE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1192248

    Patients

    Seq Age Sex Outcome Treatment
    1