BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL*

    MDR report key: 1932719 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07247
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 23, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAK TEST FAILURE ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE A DROP IN PRESSURE? NO FOR BOTH IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? NA FOR BOTH. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ASKU. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? NO FOR BOTH. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? WITH AND WITHOUT INSTRUMENTS. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO FOR BOTH 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 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 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 CHOLECYSTECTOMY PROCEDURE, BOTH DEVICES WERE LEAKING REALLY BAD THROUGH THE CASE EVEN BEFORE AN INSTRUMENT WAS INSERTED. THE SAME TROCARS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE 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 G4U32Y

    Patients

    Seq Age Sex Outcome Treatment
    1