BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI INTUITIVE SURGICAL SYSTEMS

    MDR report key: 2390198 · Received December 21, 2011

    Report

    Report Number
    MW5023591
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    December 13, 2011
    Report Date
    December 21, 2011
    Manufacturer
    DAVINCI SURGICAL
    Product Code
    GAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A ROBOTIC LUNG BIOPSY BY DR (B)(6). THE CAUTERY SPATULA HAD A PIECE OF IT COME OFF AT THE TIP CLOSEST TO THE END. MANY ATTEMPTS TO RETRIEVE IT WERE MADE (APPROX 20 MINUTES) AND ALL ATTEMPTS FAILED. SURGEON FELT IT WAS MORE POTENTIAL FOR HARM BY CONTINUING TO RETRIEVE THAN TO LEAVE IT RETAINED. SURGERY CONTINUED AS SCHEDULED AND WAS COMPLETED WITHOUT ANY FURTHER EVENTS. PLEASE NOTE THIS OCCURRED ON THE 4TH USE OUT OF 10 POSSIBLE USES OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI INTUITIVE SURGICAL SYSTEMS ROBOTIC CAUTERY SPATULA GAF DAVINCI SURGICAL 420484

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR