BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1820933 · Received October 29, 2007

    Report

    Report Number
    1527736-2007-07123
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    September 25, 2007
    Report Date
    October 3, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RADICAL PROSTATECTOMY, THE DEVICE DID NOT FIRE CORRECTLY CAUSING SCISSORED AND MALFORMED CLIPS. USED ANOTHER DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.

    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