BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3050276 · Received April 5, 2013

    Report

    Report Number
    2027111-2013-00117
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT# 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 INFORMATION, 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

    LAPAROSCOPIC CHOLECYSTECTOMY: "THE CLIP DID NOT FULLY CLOSE. AFTER PLACEMENT THE CLIPS COULD EASILY BE REMOVED. (THE SURGEONS ARE AWARE OF THE FACT THAT THE HANDLE MUST BE SQUEEZED PLASTIC TO PLASTIC)." PATIENT STATUS: "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139836 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1184664

    Patients

    Seq Age Sex Outcome Treatment
    1 ANOTHER CA090