BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1230292 · Received November 7, 2008

    Report

    Report Number
    2955842-2008-01359
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT AND CONCLUSIONS- AN INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THE VISION ISSUES EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE HIGH RESOLUTION STEREO VIEWER (HRSV) IS LOCATED ON THE SURGEON CONSOLE AND PROVIDES THE VIDEO IMAGE FOR THE SURGEON CONSOLE OPERATOR. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED HRSV. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S PROSTATECTOMY PROCEDURE, THE RIGHT EYE IN THE HIGH RESOLUTION STEREO VIEWER (HRSV) WAS DISPLAYING HORIZONTAL LINES. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL TECHNICAL SUPPORT REPRESENTATIVE, THE SITE RESET THE SURGEON SIDE CONSOLE, RESEATED THE VISION CABLE, AND CYCLED POWER, HOWEVER, THE PROBLEM WAS NOT RESOLVED. THE PT WAS UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED WHEN THE SURGICAL STAFF MADE THE DECISION TO ABORT THE PROCEDURE. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    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 A5.1P6

    Patients

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