BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1211567 · Received October 3, 2008

    Report

    Report Number
    2955842-2008-01304
    Event Type
    Other
    Date Received
    October 3, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CASE NOTES, THE INVESTIGATION CONDUCTED BY THE ISI TSE DISCOVERED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A FAULTY CAMERA CABLE. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE SYSTEM WAS REPAIRED BY PROVIDING THE SITE WITH TWO NEW CAMERA CABLES. THE DA VINCI S SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT, "ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI S SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES." 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 S TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON EXPERIENCED A PINK HUE ON THE LEFT IMAGE VIEWED THROUGH THE SURGEON'S CONSOLE. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO ASSIST THE SURGICAL STAFF IN RESOLVING THE ISSUE AND THE ISI TSE DETERMINED THAT THE IMAGE DISCOLORATION WAS DUE TO A FAULTY CAMERA CABLE, HOWEVER, THE SITE DID NOT HAVE A BACKUP CAMERA CABLE AVAILABLE FOR REPLACEMENT. THE PT WAS UNDER ANESTHESIA AND THE PORT INCISIONS HAVE BEEN MADE WHEN THE SURGICAL STAFF MADE THE DECISION TO ABORT THE PLANNED 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 A5.1 P4

    Patients

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