BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA LARGE APPLIER

    MDR report key: 2243473 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03751
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    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. UPON DISASSEMBLING, THE HOOP SPRING WAS FOUND OUT OF ITS INTENDED POSITION, JAMMING THE FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION OF THE HOOP SPRING. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE SURGEON USED THE CLIPS A FEW TIMES NORMALLY. THEN, WHEN HE FIRED THE DEVICE, THE CLIP DID NOT COME OUT AND THE JAW DID NOT OPEN. THE CLIP "STOCKED" AT THE SHAFT WITH A CLOSED SHAPE. THE SURGEON OPENED THE JAW MANUALLY AND THERE WAS NO SEVERE IMPACT ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED THREE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA LARGE APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA H43X37

    Patients

    Seq Age Sex Outcome Treatment
    1