BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1820742 · Received September 20, 2007

    Report

    Report Number
    1527736-2007-06266
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NEPHRECTOMY PROCEDURE, SURGEON WAS HAVING TROUBLE FIRING THE DEVICE. SOME OF THE CLIPS WOULD COME OUT AND FORM PROPERLY. THEN OTHER CLIPS WOULD NOT FORM OR PLACE ON TISSUE. THEY USED A TOTAL OF SEVEN DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. NO RETURN DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HX67

    Patients

    Seq Age Sex Outcome Treatment
    1