BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX

    MDR report key: 3243217 · Received July 19, 2013

    Report

    Report Number
    2027111-2013-00276
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 9, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED 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

    LAPAROSCOPIC CHOLECYSTECTOMY - "THIS WAS THE SECOND CLIP APPLIER USED DURING THE PROCEDURE. SCISSORING OF SOME OF THE CLIPS OCCURRED JUST LIKE THE PREVIOUS CLIP APPLIER. THE CLIPS DID REMAIN SECURE AT THE STRUCTURE, BUT AGAIN CLIPS FELL OUT OF THE JAW AFTER FIRING. CLIPS WERE REMOVED FROM ABDOMEN." PT STATUS: "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338983 DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX NONE GDO APPLIED MEDICAL CA090 1186685

    Patients

    Seq Age Sex Outcome Treatment
    1