BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA MED APPLIER

    MDR report key: 2001388 · Received February 25, 2011

    Report

    Report Number
    3005075853-2011-00743
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 31, 2011
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN APPENDECTOMY PROCEDURE, THE SURGEON APPLIED CLIPS TO THE VESSEL BUT THE CLIPS KEPT FALLING OFF. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CONDITION OF THE PATIENT IMMEDIATELY AFTER THE EVENT WAS STABLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. UNK G4U89D

    Patients

    Seq Age Sex Outcome Treatment
    1