BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1789508 · Received August 9, 2010

    Report

    Report Number
    3005075853-2010-04513
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE B (B)(4), MFG DATE: 12/17/2009, EXP DATE: 01/17/2014. DEVICE C (B)(4), MFG DATE: 03/09/2010, EXP DATE: 02/09/2014. DEVICE D BATCH # UNK. DEVICE E (B)(4), MFG DATE: 12/17/2009, EXP DATE: 11/17/1014. DEVICE H (B)(4), MFG DATE: 03/09/2010, EXP DATE: 02/09/2014. DEVICE F (B)(4), MFG DATE: 03/09/2010, EXP DATE: 02/09/2014. LEAK TEST FAILED INSERTING AND REMOVING TEST PROBE. DEVICE G (B)(4), MFG DATE: 12/17/2009, EXP DATE: 11/17/1014. LEAK TEST FAILED WITHOUT TEST PROBE, DAMAGED DUCKBILL. ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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 (C) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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 (D) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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 (E) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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 (F) FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. ONE POSSIBLE CAUSE FOR THIS TYPE OF ISSUE IS EXCESSIVE BENDING LOAD AS A RESULTING FROM SURGEON MANIPULATION OF INSERTED DEVICES. IN ADDITION, THE LENS OF THE OBTURATOR WAS NOTED CRACKED. THE EXPOSURE TO ETHYLENE OXIDE (EO) WHICH IS PART OF THE COMPLAINT DEVICE RETURN PROCESS MAY LEAD TO CRACK/SCRATCH LENS. THE ANALYSIS RESULTS FOUND THAT DEVICE (G) WAS RECEIVED WITH THE DUCKBILL SEAL OPEN AT THE SLIT. AS A RESULT, IT WOULD NOT OPEN AND CLOSE AS INTENDED DURING FUNCTIONAL TESTING. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (H) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THIS BATCH WAS RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, ALL SIX DEVICES WERE LEAKING THROUGHOUT THE CASE. TWO DEVICES WERE PLACED AND WERE LEAKING THEN TWO MORE DEVICES WERE PLACED AND THEY LEAKED AS WELL. TWO MORE DEVICES WERE PLACED WITH ADDITIONAL DEVICES USED TO COMPLETE THE PROCEDURE WITH THE PORT SITES LEAKING THE ENTIRE CASE. ADDITIONAL PORTS WERE CREATED WITH NO CONSEQUENCES REPORTED.

    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 G4RN30

    Patients

    Seq Age Sex Outcome Treatment
    1