BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2220343 · Received August 23, 2011

    Report

    Report Number
    3005075853-2011-03455
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 3, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE, AIR LEAKED A LOT. THE AIR LEAK STARTED IN ABOUT 40 MINUTES. WHILE A FORCEPS WAS BEING INSERTED, AIR DID NOT LEAK. A HISSING NOISE WAS HEARD FROM THE DEVICE. BESIDES, 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 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 H43P6R

    Patients

    Seq Age Sex Outcome Treatment
    1 FORCEPS