BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2011052 · Received March 8, 2011

    Report

    Report Number
    2955842-2011-00068
    Event Type
    Other
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER DETERMINED THAT THE CUSTOMER REPORTED ISSUE WAS ASSOCIATED WITH THE CAMERA CABLE INSTEAD OF THE ENDOSCOPE. 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 REPLACING THE DEFECTIVE CAMERA CABLE. THE CAMERA CABLE WAS RETURNED AND EVALUATED. ENGINEERING WAS ABLE TO REPLICATE THE REPORTED FAILURE MODE AND CONCLUDED THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS A RESULT OF CONDUCTOR DAMAGE. THE DA VINCI SI SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT, ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI SI 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 MARCH 3, 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USING THE SYSTEM TO PERFORM ANY SURGICAL TASKS FOR A DA VINCI SI PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF WAS UNABLE TO CALIBRATE THE CAMERA AND THE SYSTEM DIAGNOSTICS GENERATED A MESSAGE INDICATING THAT A POSSIBLE CAUSE WAS A DIRTY SCOPE. THE SITE POWER CYCLED THE SYSTEM, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE PATIENT HAD BEEN UNDER ANESTHESIA FOR 20 MINUTES WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other