BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2170480 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02922
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT THE SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"YES IF SO, DID THE "NOISE" PREVENT INSUFFLATION? YES PLEASE DESCRIBE THE NOISE. HISSING. WAS THERE A DROP IN PRESSURE? YES, IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? YES. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? 7 LITRE. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? YES. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? YES, IF SO, WHAT DEVICE? RF DEVICE AND ENDOSCOPIC STAPLER. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED A HAND ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON WAS USING A DEVICE AND THEY WERE ENCOUNTERING INSUFFLATIONS ISSUES; THEY REPLACED WITH IT WITH THE ANOTHER DEVICE AND AFTER THE INSTRUMENT WAS INSERTED THE PRESSURE DROPPED TO 7L AND THERE WERE HISSING SOUNDS AND THE SURGEON'S VISIBILITY WAS IMPAIRED. THEY WERE USING A RF DEVICE AND ENDOSCOPIC STAPLER WITH THE TROCARS. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH THE DEVICE BUT IT WAS A NUISANCE TO THE SURGEON. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    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 H43N00

    Patients

    Seq Age Sex Outcome Treatment
    1 RF DEVICE, ENDOSCOPIC STAPLER