BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1002859 · Received February 12, 2008

    Report

    Report Number
    2955842-2008-00030
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 11, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE INVESTIGATION CONDUCTED BY ISI FIELD SVC ENGINEERING (FSE) DISCOVERED THAT THE VISION CABLES USED TO CONNECT THE VIDEO SIGNAL DISTRIBUTION (VSD) AND THE HIGH RESOLUTION STEREO VIEWER (HRSV) WERE CROSSED. THE SYS WAS REPAIRED BY PLACING THE CABLES IN THE PROPER CONFIGURATION. 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 DURING A DA VINCI PROSTATECTOMY PROCEDURE THE CONSOLE SURGEON EXPERIENCED SYS VISION ISSUES THAT CREATED DIFFICULTIES IN GRASPING TISSUE. WITH THE ASSISTANCE OF A REGIONAL SUPPORT SPECIALIST, THE SITE ATTEMPTED TO TROUBLESHOOT THIS PROBLEM VIA TELEPHONE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. NO PT HARM WAS REPORTED. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO FINISH THE PLANNED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1200 A4.3P8

    Patients

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