BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 1983136 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00522
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 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). THE ANALYSIS RESULTS OF THE FOUND THAT THE DEVICE WAS RECEIVED WITH THE DUCKBILL OUT OF POSITION. ONE POTENTIAL CAUSE FOR THE DAMAGE FOUND MAY BE THE SNAGGING OF AN INSTRUMENT DURING INSERTION. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE DUCKBILL OUT OF POSITION ISSUES. IN ADDITION, THE LENS OF THE OBTURATOR WAS NOTED CRACKED. THE EXPOSURE TO ETHYLENE OXIDE (EO) WHICH IS PART OF THE COMPLAINT DEVICE RETURN PROCESS MAY LEAD TO CRACK/SCRATCH LENS. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, AIR LEAKED FROM THE DEVICE. THE ABDOMINAL AIR PRESSURE WAS 8 ML AND THE FLOW RATE WAS 10 ML. AFTER THE OUTER SEAL WAS REMOVED, THE OUTER SEAL COULD NO LONGER BE SET TO THE INSTRUMENT AGAIN. ANOTHER DEVICE WAS USED 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 G4TU97

    Patients

    Seq Age Sex Outcome Treatment
    1