BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA SMALL APPLIER

    MDR report key: 2211745 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03300
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 22, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? UNK. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? UNK. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? NO. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? UNK. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? UNK. WERE ANY UNEXPECTED NOISES HEARD? UNK. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? UNK. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNK. WHAT WERE THE INDICATIONS FOR SURGERY? UNK WHAT WAS FOUND? UNK. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? UNK. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A CORONARY ARTERY BYPASS GRAFT. THE DEVICE SPIT THE CLIPS AND THEN JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA SMALL APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H4320X

    Patients

    Seq Age Sex Outcome Treatment
    1