BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2032810 · Received March 29, 2011

    Report

    Report Number
    3005075853-2011-01250
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE SLEEVE 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. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THE TROCAR WAS LEAKING. THEY KEPT LOSING PNEUMO. A NEW TROCAR WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT 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