BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1841059 · Received September 22, 2010

    Report

    Report Number
    3005075853-2010-05463
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TEST FAILURE, DUCKBILL. FIVE OF THE RETURNED PRODUCT HAVE BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RETURNED IN GOOD 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 FOUND THAT DEVICE (B) WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. 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. BATCH # G9JM78 MFG DATE 03/17/2010; EXP DATE 02/17/2015. (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B1) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. BATCH # G9JM78 MFG DATE 03/17/2010; EXP DATE 02/17/2015 (B)(4) LEAK TEST FAILURE. THE ANALYSIS RESULTS FOUND THAT DEVICE (B2) WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. 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. BATCH # G9JM78 MFG DATE 03/17/2010; EXP DATE 02/17/2015 (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (B4) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. BATCH # G9JM78 MFG DATE 03/17/2010; EXP DATE 02/17/2015 (B)(4) LEAK TEST FAILURE. THE ANALYSIS RESULTS FOUND THAT DEVICE (B5) WAS RETURNED IN GOOD 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. BATCH # G9JM78 MFG DATE 03/17/2010; EXP DATE 02/17/2015 (B)(4). NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT NEAR THE END OF A PANCREATIC BILARY DIVERSION + GASTRIC SLEEVE PROCEDURE, THERE WAS A HISSING SOUND WITH THE USE OF THIS DEVICE AND IT WAS EXTREMELY NOTICABLE THAT IT WAS LEAKING PNEUMO. THEY COULD NOT IDENTIFY WHERE THE LEAKAGE WAS COMING FROM. UNABLE TO VISUALIZE. THE LEAKAGE OCCURRED BOTH PRIOR TO INSTRUMENTS BEING PUT THROUGH THE DEVICE, AND WHILE THE INSTRUMENTS WERE BEING USED IN THE DEVICE. DURING THE BEGINNING OF THE CASE THE SURGEON HAD USED 10 MM INSTRUMENTS. WHEN THE LEAKAGE OCCURRED HE WAS USING 5MM INSTRUMENTS WITH A REDUCER CAP. THEY NORMALLY USE ONE TANK OF GAS FOR THIS PROCEDURE, THEY ENDED UP USING TWO TANKS INSTEAD. THE PROCEDURE WAS DELAYED BY 20 MINUTES, PARTLY BECAUSE THE CASE WAS COMPLICATED AND PARTLY BECAUSE OF DIFFICULTY WITH THE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RR2C

    Patients

    Seq Age Sex Outcome Treatment
    1