BEUDAMED
    FDA Adverse Event Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 2222651 · Received July 19, 2011

    Report

    Report Number
    2027111-2011-00072
    Date Received
    July 19, 2011
    Date of Event
    June 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO THE MANUFACTURER FOR REVIEW. A DEVICE HISTORY REPORT OF THE INCIDENT IS TO BE CONDUCTED AND A FOLLOW-UP REPORT WILL BE SENT WITHIN 30 DAYS OR UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: LAPAROSCOPIC CHOLECYSTECTOMY AND SLEEVE GASTRECTOMY - "DURING PLACING CLIPS ON THE CYSTIC ARTERY, THE CLIPS CROSSED EACH OTHER AND DIDN'T CLOSE PROPERLY, THE CLIPS WERE OVER CROSSING AND THE TWO ENDS OF THE CLIPS CROSSED. WHEN APPLYING CLIPS FROM A NEW CLIP APPLIER, THE CLIPS DIDN'T CLOSE TIGHTLY AND WERE HANGING LOOSE TO STRUCTURES, SURGEONS REMOVED THOSE CLIPS WITH A GRASPER FROM INSIDE THE PATIENT. ANOTHER CLIP APPLIER WAS OPENED AND IT WAS FIRING AN EMPTY CLIP FOLLOWED BY A CLIP THEN AN EMPTY CLIP AND SO ON. IN ADDITION TO THE CLIPS BEING NOT SECURE AND FALLING OFF FROM THE SLIGHTEST MANEUVER, WHEN THE SURGEONS REMOVED THE CLIPS, THE METAL WAS VERY EASY TO OPEN AND CLOSE. THE SURGEONS WERE NOT SATISFIED WITH THE PERFORMANCE OF THE CLIP APPLIER OR THE STRENGTH OF THE METAL AND TOLD US THIS WAS NOT THE FIRST INCIDENT FOR CLIPS TO FALL OFF AFTER BEING CLOSED, IN ADDITION TO SEVERAL REPORTS FROM DIFFERENT HOSPITALS OF THE SAME EVENT THAT THE CLIP DO NOT CLOSE SECURELY. PATIENTS ARE DOING FINE, CLIP APPLIERS FROM AUTOSUTURE WERE THEN USED TO COMPLETE THE OPERATION AND CLOSED PERFECTLY TIGHT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention