BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*TROCAR

    MDR report key: 1983134 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00521
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 25, 2011
    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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE DEVICE DOES NOT HAVE AN OBTURATOR. THE OBTURATOR IS THE PIECE OF THE TROCAR THAT HAS THE BATCH STAMPED. NO BATCH NUMBER WAS AVAILABLE; THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. DEVICE B ADDITIONAL INFORMATION: BATCH # UNK EXPIRATION DATE: UNK MANUFACTURING DATE: UNK (B)(4) DUCKBILL, LEAK TEST FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON HAS FOUND AIR LEAKS FROM THE TROCAR. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1