BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 3122770 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02476
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 28, 2013
    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
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? ¿ YES THERE WAS A HISSING SOUND THROUGHOUT THE PROCEDURE THROUGH THE TROCAR. A 5MM KARL STORZ CAMERA WAS INTRODUCED IN THE TROCAR. IF SO, DID THE NOISE PREVENT INSUFFLATION? -- YES, THE SURGEON HAD A TOUGH TIME TO MAINTAIN THE SURGICAL FIELD AND OPERATE. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YES THERE WAS A DROP IN PRESSURE, REDUCING THE OPERATING SPACE. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? THE 1.5-2L/MIN AND PRESSURE 12MM OF HG. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO, IT WAS USED AS A CAMERA PORT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK WITHOUT THE TEST PROBE INSERTED THROUGH THE DEVICE. 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 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 APPENDECTOMY PROCEDURE, THE SURGEON USED THE DEVICE AND A 5MM CAMERA WAS INTRODUCED THEN THE TROCAR STARTED LEAKING AT THE UNIVERSAL SEAL. HE TRIED TO REMOVE THE TROCAR AND TAP IT ON MAYO. BUT IT DID NOT HELP AS THE LEAK CONTINUED THROUGHOUT THE PROCEDURE REDUCING THE PNEUMOPERITONIUM AND COMPROMISING THE SURGICAL FIELD. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223827 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4C12U

    Patients

    Seq Age Sex Outcome Treatment
    1 5MM CAMERA