BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2142241 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02614
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: NO CLIPS FELL INTO THE PATIENT'S BODY.

    Additional Manufacturer Narrative · 1

    (B)(4). HOOP SPRING THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE TRIGGER COULD NOT BE COMPLETELY ACTIVATED DUE TO THE FIRING MECHANISM WAS JAMMED. IN ORDER TO EVALUATE THE CONDITION OF THE DEVICE'S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE HOOP SPRING WAS FOUND OUT OF ITS INTENDED POSITION, JAMMING THE FIRING MECHANISM AND MAKING THE ANTIBACKUP FEATURE NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE HOOP SPRING. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE ANTIBACKUP FAILURE MAY LEAD TO DROPPING CLIPS. IN ORDER TO EVALUATE THE PROPER ASSEMBLY OF THE HOOP SPRING, IT WAS REASSEMBLED. UPON FIRING, THE DEVICE PERFORMED AS INTENDED; THE CLIPS WERE FED AND PROPERLY FORMED. 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 AN OPEN CORONARY ARTERY BYPASS GRAFT, THE CLIP FELL OUT FROM THE JAW AT THE FIRST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1