BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2212226 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03312
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 4, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WAS THERE A DROP IN PRESSURE? UNK. IF YES, DID THIS AFFECT THE VISIBILITY OF THE SURGEON? UNK. WHAT WAS THE GAS CONSUMPTION RATE OR VOLUME (LITER/MINUTE)? 10MMHG AND HIGH FLOW. WERE YOU ABLE TO IDENTIFY WHERE THE LEAK WAS COMING FROM? YES. WAS A DEVICE INSERTED IN THE TROCAR DURING THE LEAKING? NO. IF SO, WHAT DEVICE? NA. WAS ANY TORQUE BEING APPLIED TO THE TROCAR OR DEVICE? UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, AIR LEAKED A LOT. A BOO SOUND WAS HEARD FROM THE DEVICE. THE ABDOMINAL PRESSURE WAS 10MMHG AND HIGH FLOW. THE DOCTOR HELD THE HOUSINGS AND THE DEVICES WERE USED AS-IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43TOJ

    Patients

    Seq Age Sex Outcome Treatment
    1