BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2212222 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03311
    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. THE AIR LEAK STARTED IN ABOUT 30 MINUTES. WHILE A FORCEPS WAS BEING INSERTED, AIR DID NOT LEAK. A HISSING NOISE WAS HEARD FROM DEVICE. THERE WAS A PIN HOLE IN THE VALVE OF THE DEVICE. THE SIZE OF THE PIN HOLE WAS LESS THAN 5MM. 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 H43M37

    Patients

    Seq Age Sex Outcome Treatment
    1 FORCEPS