BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1993942 · Received February 16, 2011

    Report

    Report Number
    2955842-2011-00050
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE SURGEON STATED VIA EMAIL, THE INJURY WAS NOT CAUSED BY A ROBOTIC INSTRUMENT OR ARM MALFUNCTION. THE PATIENT RECOVERED COMPLETELY FROM THE OPERATION AND HAS BEEN HOME FOR SEVERAL WEEKS. PER THE INFORMATION PROVIDED BY THE SURGEON, INTUITIVE SURGICAL DETERMINED THAT THE PATIENT INJURY WAS UNRELATED TO THE PERFORMANCE OF THE DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S LOBECTOMY PROCEDURE, AN INJURY TO A BRANCH OF THE PATIENT'S MAIN PULMONARY ARTERY OCCURRED DURING ITS DISSECTION, REQUIRING THAT THE SURGEON CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SYSTEM INSTRUMENTS & ACCESSORIES