BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA LARGE APPLIER

    MDR report key: 1112657 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01058
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    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

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS WILL NOT HOLD AFTER PLACING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA LARGE APPLIER GDO ETHICON ENDO-SURGERY, LLC NA E4KL43

    Patients

    Seq Age Sex Outcome Treatment
    1