BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 1994051 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00674
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON EVALUATION, A TEST 5MM DEVICE WAS INSERTED AND REMOVED THROUGH THE TROCAR WITHOUT ANY ANOMALIES NOTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENT REPORTED. IN ADDITION, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT SLIT; HOWEVER, THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE DEVICE DOES NOT HAVE AN OBTURATOR. THE OBTURATOR IS THE PIECE OF THE TROCAR THAT HAS THE BATCH STAMPED. NO BATCH NUMBER WAS AVAILABLE; THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE LAPAROSCOPIC BAND PLACEMENT, UPON REMOVAL OF THE DISSECTOR THE SURGEON WITHDREW THE DEVICE THROUGH THE TROCAR AND FELT RESISTANCE. AFTER TWO ATTEMPTS THE SURGEON REMOVED BOTH THE 5MM TROCAR AND THE DISSECTOR AS ONE UNIT AND THE TROCAR IS STILL STUCK ON THE DISSECTOR. ANOTHER 5MM TROCAR WAS USED TO COMPLETE THE CASE. THE DISSECTOR WAS NO LONGER NEEDED SINCE THE BAND WAS ALREADY PASSED. THIS WAS THE FIRST BAND PLACEMENT FOR THE PATIENT. THE DISSECTOR AND TROCAR ARE STUCK TOGETHER AND WILL BE RETURNED FOR ANALYSIS.

    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 DISSECTOR