BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1770789 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04228
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION, THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, BOTH THE TROCAR AND THE SLEEVE STARTED TO LEAK AT THE BEGINNING OF THE PROCEDURE. THERE WAS A MAJOR PROBLEM IN KEEPING THE GAS IN THE ABDOMEN; IT WAS TECHNICALLY VERY HARD FOR THE SURGEON AND THE ASSISTANT TO PERFORM THE PROCEDURE. THEY CHANGED TO MULTIPLE USE TROCAR FOR THE GAS AND THEY ALSO CHANGED TO A DIFFERENT TROCAR. IT WAS BETTER BUT NOT OPTIMAL. SINCE THE PATIENT WAS VERY SHORT, THE PROCEDURE WAS DIFFICULT TO PERFORM WITH THE EXTRA LONG TROCAR. THEY USED ABOUT 215 L GAS. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 75 MINUTES AND THE PATIENT WAS UNDER ANESTHESIA FOR A LONGER PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4T243

    Patients

    Seq Age Sex Outcome Treatment
    1