BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1904538 · Received November 22, 2010

    Report

    Report Number
    3005075853-2010-06628
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    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 DEVICE FOUND THAT ONLY THE UNIVERSAL SEAL ASSEMBLY WAS RECEIVED; IT WAS NOTED IN GOOD CONDITION. THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE 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 AN UNKNOWN PROCEDURE, THE DEVICE WAS SENDING OUT MULTIPLE CLIPS ON EACH FIRING. THEY OPENED A NEW ONE AND IT DID THE SAME THING. THEY THEN CHANGED TO A DIFFERENT DEVICE WHICH WORKED FINE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, AIR LEAKED IN ABOUT 30 MINUTES. THE VALVE OF THE INNER SEAL HAS A DEFLECTION. ALL INSERTED FORCEPS THROUGH THE DEVICE WERE 5MM. WHEN THE VALVE WAS CORRECTED WITH FINGERS, THE AIR LEAK STOPPED. THE EVENT OCCURRED SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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. G4TN9D

    Patients

    Seq Age Sex Outcome Treatment
    1