BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1853143 · Received October 5, 2010

    Report

    Report Number
    3005075853-2010-05581
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TEST FAILED INSERTING AND REMOVING TEST PROBE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC DONOR NEPHRECTOMY PROCEDURE, THE SURGEON ADVISED OF GAS LEAKING FROM THE UNIVERSAL SEAL OF THE TROCARS. THIS OCCURRED WHEN USING A 5MM DEVICE IN THE PORT AND PUTTING CONSIDERABLE TORQUE ON THE TROCAR. THE SURGEON USED A HAND ASSISTED APPROACH AND INSERTED HIS HAND DIRECTLY INTO THE PATIENT THROUGH A DIRECT INCISION. THIS LEAD TO SIGNIFICANT LEAKING THROUGHOUT THE CASE. THE SALES REP ADVISED THE SURGEON TO TWIST THE TROCAR AROUND SO THAT THE TORQUE WAS PLACED AGAINST THE SOLID PARTS OF THE TROCAR HEAD AND NOT AGAINST WHERE THE TROCAR HEAD ATTACHES TO THE CANNULA. THIS HELPED BUT THERE WAS STILL LEAKING DETECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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 F4NM1P

    Patients

    Seq Age Sex Outcome Treatment
    1