BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED APPLIER

    MDR report key: 2211824 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03303
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 27, 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
    AU
    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: HOW MUCH BLOOD LOSS? NOT MUCH, THE SURGEON ALLOYED THE VESSEL IMMEDIATELY AFTER SETTING THE CLIP. WAS BLOOD PRODUCT ADMINISTRATED? NO. WERE THE CLIPS FORMED PROPERLY? PLEASE DESCRIBE THE SHAPE OF THE CLIP. THE CLIP WAS FORMED PROPERLY AS USUAL, THE SHAPE WAS NORMAL, HOWEVER IT SEEMED THAT THE CLIP WAS SHARP UND CUT THE VESSEL. WHAT IS THE PATIENTS CURRENT STATUS? THE PATIENT IS ALRIGHT, THERE WERE NO CONSEQUENCES FOR THE PATIENT. WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? FIRST FIRING OF THE CLIP. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? ON AN ARTERY, DIAMETER OF 3MM. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NO. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). SIX DEVICES WERE RECEIVED INSIDE THEIR ORIGINAL PACKAGE AND IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICES WERE TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICES WERE CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE DEVICES WERE 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 BY THE AFFILIATE THAT DURING A DIEP-LAP PROCEDURE, ALONE THROUGH SETTING THE CLIPS THE VESSEL WAS CUT AND WENT IN FURTHER CONSEQUENCES TO A MASSIVE BLEEDING (THE VESSEL HAD A DIAMETER OF CA. 3MM). THE USE OF THE DEVICE WAS ABSOLUTELY CORRECT. THE SURGERY TIME WAS PROLONGED BY 15 MINUTES, AND THERE WAS LOSS OF BLOOD. THE SURGEON ALLOYED THE VESSEL. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. SIX DEVICES WILL BE RETURNING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H43244

    Patients

    Seq Age Sex Outcome Treatment
    1