BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI BALLOON PORT, 12MM, ECM

    MDR report key: 1053088 · Received May 27, 2008

    Report

    Report Number
    2955842-2008-01031
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 23, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON PORT ACCESSORY WAS DISCARDED BY THE CUSTOMER AND THEREFORE WILL NOT BE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. THE DA VINCI BALLOON PORT INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS. CAUTION: OVER INFLATION OF THE BALLOON MAY CAUSE IT TO RUPTURE. NOTE THAT 4CC OF FLUID WILL COMPLETELY INFLATE THE BALLOON AND FURTHER INFLATION IS UNNECESSARY AND WILL INCREASE THE RISK OF BALLOON RUPTURE. INSERTION AND REMOVAL OF INSTRUMENTS THROUGH THE CANNULA SHOULD BE DONE CAREFULLY TO PREVENT UNINTENTIONAL DAMAGE TO THE INTERNAL SEALS, WHICH MAY COMPROMISE INSUFFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SINGLE VESSEL SMALL THORACOTOMY PROCEDURE, THE DA VINCI BALLOON PORT ACCESSORY "BROKE" AND CO2 BEGAN TO LEAK FROM THE CANNULA. THE SURGEON DECIDED NOT TO REPLACE THE BALLOON PORT ACCESSORY AND COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PROCEDURE WAS LENGTHENED BY APPROXIMATELY 30 MINUTES DUE TO THE CO2 LEAKAGE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI BALLOON PORT, 12MM, ECM ENDOSCOPIC INSTRUMENT ACCESSORY GCJ INTUITIVE SURGICAL, INC. 400193-02 07147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI SURGICAL SYSTEM INSTRUMENTS