BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1821143 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05287
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 30, 2007
    Report Date
    July 31, 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
    TN, US
    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 OPEN NEPHRECTOMY PROCEDURE, THE CLIPS WERE SCISSORING AND DOUBLE FEEDING. THE CLIPS WERE ALSO EJECTING FROM THE DEVICE. SOME FELL INTO THE PATIENT AND WERE RETRIEVED WITH FORCEPS. THE SAME INCIDENT OCCURRED WITH TWO DEVICES. THE PROCEDURE WAS COMPLETED WITHOUT THE NEED OF A NEW DEVICE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1