BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 1930273 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07208
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    August 30, 2010
    Report Date
    November 25, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WERE ANY NOISES SUCH AS WHISTLING OR HISSING HEARD? YES DESCRIBE THE NOISE: SLOW HISS. IF YES, DID THE NOISE PREVENT INSUFFLATION? YES. WAS THERE A DROP IN PRESSURE? YES. DID THIS AFFECT THE SURGEON'S VISIBILITY? NO. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITRE/MINUTE)? TEN. WAS THE USER ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? YES IF YES, WHERE? MEMBRANE. WAS A DEVICE INSERTED INTO THE TROCAR DURING LEAKING? YES. IF SO, WHAT WAS THE DEVICE? CAMERA. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? NO. MEMBRANE WAS LEAKING, COULD NOT INSUFFLATE AND HOLD. THE RETURNED PRODUCT HAS BEEN IDENTIFIED AS PART OF THE VOLUNTARY RECALL OF ENDOPATH XCEL WITH OPTIVIEW TECHNOLOGY.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS LEAKING AND THEY COULD NOT INSUFFLATE THE PATIENT'S ABDOMEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO 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 G4TJ04

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR