BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1771772 · Received July 28, 2010

    Report

    Report Number
    3005075853-2010-04249
    Event Type
    Malfunction
    Date Received
    July 28, 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). LEAK TEST FAILED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE 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, THE SLEEVE AND THE TROCAR LEAKED FROM THE BEGINNING OF THE PROCEDURE. IT WAS IN THE INSERTION OF THE TROCAR AND YOU COULD HEAR THE HISSING SOUND. THEY HAD TO USE MORE GAS THAN NORMAL, ABOUT 100 LITERS, INSTEAD OF 50-60 LITERS. THEY ALSO HAD TO CHANGE TROCARS TO A DIFFERENT CODE AND A MULTIPLE USE TROCAR. THAT HELPED A LOT, BUT STILL THERE WAS A SMALL LEAK FROM ONE OF THE OTHER SLEEVES. AS A RESULT OF THE COMPLICATIONS ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 45 MINUTES AND THE PATIENT WAS UNDER ANESTHESIA FOR A LONGER PERIOD OF TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    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