BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH*XCEL KIL TIP TROC PAK

    MDR report key: 1868117 · Received October 13, 2010

    Report

    Report Number
    3005075853-2010-05846
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SLEEVE ASSEMBLY THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RECEIVED WITH EVIDENCES THAT SUGGESTED THAT IT WAS DISASSEMBLED BY A THIRD PARTY. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS OF DEVICE (C) WAS RECEIVED WITH THE DUCKBILL DEFORMED; MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. 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 ANALYSIS RESULTS OF DEVICE (D) FOUND THAT IT WAS RECEIVED WITH THE DUCKBILL DEFORMED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A PNEUMO LEAK THROUGH THE SEAL OF THE TROCARS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH*XCEL KIL TIP TROC PAK LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. G4T16P

    Patients

    Seq Age Sex Outcome Treatment
    1