BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1820992 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06670
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 17, 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 Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY PROCEDURE, THE CLIPS SCISSORED AND OPENED DURING THE PROCEDURE. A HEMORRHAGE OCCURRED WHICH WAS CONTROLLED BY MANUAL SUTURE. NO TRANSFUSION WAS PERFORMED. THERE WERE NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HD7L

    Patients

    Seq Age Sex Outcome Treatment
    1