BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT ISI DAVINCI BALLOON PORT TROCAR - 12MM

    MDR report key: 1842336 · Received August 30, 2010

    Report

    Report Number
    3003898360-2010-00396
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 19, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A DAVINCI SURGICAL PROCEDURE, THE PLASTIC TIP OF THE TROCAR WITH THE BALLOON BROKE, AND PIECES FELL INTO THE PT. BROKEN PIECES OF THE BALLOON WERE RETRIEVED FROM THE PT AS WELL AS THREE PIECES OF PLASTIC, HOWEVER, THE SURGEON BELIEVES THAT PIECES OF THE PLASTIC MAY STILL REMAIN IN THE PT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT TROCAR AND NO PT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT ISI DAVINCI BALLOON PORT TROCAR - 12MM BALLOON PORT TROCAR GCJ TELEFLEX MEDICAL NA 01C0900046

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR