BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI BALLOON PORT

    MDR report key: 1864830 · Received September 28, 2010

    Report

    Report Number
    3003898360-2010-00413
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 15, 2010
    Report Date
    September 8, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A SURGICAL PROCEDURE, IT WAS NOTED A LOSS OF INSUFFLATION. THE INSTRUMENT WAS REMOVED FROM THE PATIENT AND THE TROCARS WERE CHECKED. IT WAS NOTED THAT A PORTION OF THE BALLOON OF THE DA VINCI PORT FELL IN THE PATIENT. ALSO NOTICED WAS THE DA VINCI CANNULA WAS SHATTERED. THE CAMERA WAS REMOVED AND UNDOCKED THE ROBOT FROM THE CAMERA PORT. THE TROCAR WAS REPLACED WITH A NEW ONE, REDOCKED AND PROCEDURE WAS COMPLETED. A SMALL THORACOTOMY INCISION WAS MADE TO RETRIEVE THE BALLOON PORTION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI BALLOON PORT DA VINCI BALLOON PORT NAY TELEFLEX MEDICAL NA 01D0900249

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention