BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2856810 · Received December 4, 2012

    Report

    Report Number
    2955842-2012-01171
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER DETERMINED THAT THE VISION ISSUE EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE CAMERA CONTROLLER UNIT (CCU), THE VIDEO DIGITIZER AND THE SYSTEM VIDEO PROCESSOR PRINTED CIRCUIT ASSEMBLY (SVP PCA) BOARD. THE CCU CALIBRATES AND ADJUSTS THE BRIGHTNESS LEVELS OF THE VIDEO IMAGE FROM THE TWO HIGH MAGNIFICATION CAMERA HEADS. THE CCU THEN FEEDS THE IMAGE THROUGH THE VIDEO SYNCHRONIZER TO THE SURGEON'S CONSOLE AND ASSISTANT MONITOR. THE DIGITIZER CONVERTS THE ANALOG VIDEO IMAGES RECORDED BY THE CAMERA INTO A DIGITAL FORMAT SO THAT IT CAN BE TRANSMITTED OVER THE FIBER-OPTIC CABLE AND COMBINED WITH OTHER IMAGES (SUCH AS THE USER INTERFACE ICONS AND TEXT OR AN AUXILIARY IMAGE FROM AN ULTRASOUND OR OTHER SOURCE). THE S5VP PCA IS THE VIDEO PROCESSOR FOR THE SYSTEM WHICH CREATES THE DISPLAY FOR THE HIGH RESOLUTION STEREO VIEWER. THE SYSTEM WAS REPAIRED BY REPLACING THE CCU, THE VIDEO DIGITIZER AND THE SVP PCA BOARD. THE REPLACED AFFECTED PARTS WERE RETURNED TO ISI FOR EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS PERFORMED AND ENGINEERING WAS UNABLE TO REPLICATE THE REPORTED FAILURE MODE WITH THE RETURNED SVP PCA BOARD AND CCU. HOWEVER, ENGINEERING WAS ABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE WITH THE VIDEO DIGITIZER. EVALUATION OF THE DIGITIZER FOUND THAT THE COAX CABLE ON THE DIGITIZER WAS DAMAGED, THUS CAUSING THE VISION ISSUE EXPERIENCED BY THE SITE. THE CABLE COAX CABLE WAS REPLACED TO REPAIR THE DIGITIZER. ON (B)(4) 2012, ISI CONTACTED RN, (B)(6) (B)(4) HOSPITAL. LEON INDICATED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. (B)(6) INDICATED THAT THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND TO THE BEST OF HIS KNOWLEDGE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATION. AS OF (B)(4) 2012, 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 HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED LEFT EYE VISION LOSS THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV) ON THE SURGEON SIDE CONSOLE AND THE TOUCHSCREEN MONITOR. PRIOR TO CONTACTING ISI FOR TECHNICAL SUPPORT ASSISTANCE, THE SITE SWAPPED THE CAMERA HEAD AND CAMERA CABLE; HOWEVER, THE ISSUE RECURRED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON MADE THE DECISION TO PERFORM THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM 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 A51.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S ACCESSORIES