BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE APPLIER 10MM 3/BOX

    MDR report key: 3181613 · Received June 14, 2013

    Report

    Report Number
    2027111-2013-00225
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    LAP CHOLE - "SURGEON PLACED 3 CLIPS SUCCESSFULLY. PLACED 4 CLIPS (VERY CLOSELY PLACED TOGETHER) ON VESSEL. SURGEON MADE CUT BETWEEN 1ST AND 2ND CLIP. SECOND CLIP BEGAN TO SLIP OFF. DISCUSSES WITH SURGEON THAT 3RD AND 4TH CLIP WERE SECURE AND HE AGREED." PT STATUS: "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272185 DIRECT DRIVE DISPOSABLE APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1194493

    Patients

    Seq Age Sex Outcome Treatment
    1