BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2050910 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01460
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 22, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY NOISES HEARD SUCH AS "WHISTLING" OR "HISSING"? IF SO, DID THE "NOISE" PREVENT INSUFFLATION? PLEASE DESCRIBE THE NOISE. ASKU. WAS THERE A DROP IN PRESSURE? IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? ASKU. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? ASKU. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? ASKU. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? IF SO, WHAT DEVICE? ASKU. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? ASKU. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO DETECT ANY LEAKING ISSUES. UPON EVALUATION OF THE DEVICE, IT WAS FUNCTIONALLY LEAK TESTED AND PASSED. THE DEVICE WAS FULLY FUNCTIONAL ACCORDING TO THE MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE CAUSED INSUFFLATION ISSUES. NO OTHER INFORMATION IS AVAILABLE. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1