BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1810049 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07532
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 22, 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
    PM
    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 AN UNKNOWN CASE, THE CLIPS WERE MALFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA A4AP95

    Patients

    Seq Age Sex Outcome Treatment
    1