BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1771815 · Received July 28, 2010

    Report

    Report Number
    3005075853-2010-04246
    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 OF THE DEVICE FOUND THAT IT WAS RETURNED IN GOOD VISUAL CONDITION. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. ONE POSSIBLE CAUSE FOR THIS TYPE OF ISSUE IS EXCESSIVE BENDING LOAD AS A RESULTING FROM SURGEON MANIPULATION OF INSERTED DEVICES. 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; THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. 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 ANOTHER 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 F4PY9E

    Patients

    Seq Age Sex Outcome Treatment
    1