BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2122178 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02384
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE, THE MEDIUM CLIP APPLIER DEVICE WAS FIRED AND THERE WAS NOT A CLIP DEPLOYED. IT TORE THE VESSEL. THE LARGE CLIP APPLIER TORE THE VESSEL EVERY TIME IT WAS USED/FIRED. NO OTHER DETAILS OF THE EVENT WERE PROVIDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H43E96

    Patients

    Seq Age Sex Outcome Treatment
    1