BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3872136 · Received June 13, 2014

    Report

    Report Number
    2955842-2014-03635
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAMERA HEAD AND CAMERA CABLE WERE RECEIVED BY ISI FOR FAILURE ANALYSIS INVESTIGATION. INVESTIGATION FOUND THAT THE CAMERA HEAD EXHIBITED MECHANICAL SHOCK, AS THE HOUSING COMPONENTS WERE DAMAGED. THE CAMERA HEAD WAS OUT OF ALIGNMENT AND THE FIBER OPTIC CABLE WAS DAMAGED. THE CAMERA WAS RE-ADJUSTED AND THE FIBER OPTIC CABLE WAS REPLACED TO REPAIR THE CAMERA HEAD. FAILURE ANALYSIS INVESTIGATION WAS UNABLE FIND ANY TROUBLE WITH THE RETURNED CAMERA CABLE, AS FUNCTIONAL TESTING ON AN IN-HOUSE IS3000 SYSTEM FOUND THAT IT FUNCTIONED WITHIN SPECIFICATIONS. THE VIDEO ON THE VISION SIDE CART MONITOR, SURGEON SIDE CART HIGH RESOLUTION STEREO VIEWER AND PATIENT SIDE CART MONITOR WORKED FINE WITHOUT ANY ISSUES NOTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI BLADDER DIVERTICULUM PROCEDURE, THE SURGEON EXPERIENCED A VISION ISSUE, CAUSING THE SURGEON TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. BASED ON THE INFORMATION PROVIDED THE SITE DID NOT HAVE A REPLACEMENT CAMERA HEAD. THE DA VINCI SI SURGICAL SYSTEM USER'S MANUAL EXPLICITLY STATES THAT ENVIRONMENTAL OR EQUIPMENT FAILURES MAY CAUSE THE DA VINCI SI SURGICAL SYSTEM TO BECOME UNAVAILABLE. THE SURGICAL TEAM SHOULD ALWAYS HAVE A BACKUP EQUIPMENT AND INSTRUMENTATION AVAILABLE, AND BE PREPARED TO CONVERT TO ALTERNATIVE SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI BLADDER DIVERTICULUM PROCEDURE, THE IMAGE THROUGH THE LEFT LENS OF THE CAMERA HEAD WAS OUT OF FOCUS. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE SITE SWAPPED THE ENDOSCOPE; HOWEVER, THE ISSUE RECURRED. THE TSE THEN INSTRUCTED THE SITE TO SWITCH THE RIGHT LENS OF THE CAMERA HEAD TO 2D IMAGING; HOWEVER, THE IMAGE APPEARED TO BE SLIGHTLY IMPROVED. THE TSE ASKED THE SITE TO SWAP THE ENDOSCOPE WITH A 3RD REPLACEMENT ENDOSCOPE; HOWEVER, THE ISSUE PERSISTED AND THE FONTS IN THE LEFT LENS IMAGE WERE BLURRY AS WELL. THE VISION ISSUE EXPERIENCED BY THE SITE PERSISTED AFTER THE SITE REBOOTED THE SYSTEM. THE SITE DID NOT HAVE A REPLACEMENT CAMERA HEAD. UNABLE TO RESOLVE THE ISSUE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM OR INJURY WAS REPORTED. ISI CONTACTED THE ROBOTICS COORDINATOR AT THE SITE. ACCORDING TO THE ROBOTICS COORDINATOR THE SURGEON WAS HALF WAY THROUGH THE SURGICAL PROCEDURE WHEN THE VISION ISSUE OCCURRED. THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. THE INVESTIGATION CONDUCTED BY THE ISI FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE VISION ISSUE EXPERIENCED BY THE SITE WAS ASSOCIATED WITH A FAULTY CAMERA HEAD AND CAMERA CABLE. THE CAMERA PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI VISION SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE THEN ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. 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 CAMERA CABLE AND CAMERA HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349596 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other