BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 2100504 · Received May 24, 2011

    Report

    Report Number
    3005075853-2011-02097
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 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
    UK
    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 DONOR NEPHRECTOMY PROCEDURE, THE TROCAR WAS USED AS A MAIN ENTRY PORT WITH GAS ATTACHED, IT BEGAN LEAKING WHILE USING A 5MM ULTRASONIC DEVICE THROUGH IT. CAUSED INCREASED IRRITATION AS ABDOMEN KEPT DEFLATING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5MM ULTRASONIC