BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2181767 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-02940
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 7, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A HIGH ANTERIOR RESECTION PROCEDURE, THE TROCARS BOTH STARTED TO LEAK DURING THE PROCEDURE ONCE AN INSTRUMENT WAS INSERTED. ONCE THE INSTRUMENT WAS REMOVED THE HISSING STOPPED. NO INSUFFLATION WAS LOST AND THE PATIENT WAS NOT PUT IN SEVERE DANGER ACCORDING TO THE CONSULTANT BUT IT ADDED TO HIS FRUSTRATION AND CAUSED THEM TO USE MORE CO2. BOTH TROCARS WERE INSERTED CORRECTLY AND NOT PUT UNDER ANY MORE PRESSURE THAN IS NORMAL OR REQUIRED FOR THIS TYPE OF SURGERY. THEY CONTINUED TO USE BOTH THE TROCAR AND STABILITY SLEEVE. THE PROCEDURE WAS PROLONGED FIVE MINUTES. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1