BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2182838 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03059
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS WHISTLING OR HISSING? ---NO INFORMATION. IF SO, DID THE NOISE PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. ---NO INFORMATION. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? ---NO INFORMATION. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ---NO INFORMATION. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ---VALVE. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? ---NO INFORMATION. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ---NO INFORMATION. THE ANALYSIS RESULTS FOUND THAT THE DEVICES (A AND B) WERE RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION OF THE DEVICES, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICES WERE 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. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE INSUFFLATIONS ISSUES. THE BATCH RECORDS WERE 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 REQUESTED: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? IF SO, DID THE "NOISE" PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, AIR LEAKED A LOT. THE DEVICES WERE USED AS-IS TO COMPLETE THE CASE. 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 H43M37

    Patients

    Seq Age Sex Outcome Treatment
    1