BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3328401 · Received September 5, 2013

    Report

    Report Number
    2955842-2013-03390
    Event Type
    Other
    Date Received
    September 5, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOUCH SCREEN WAS RETURNED TO AND EVALUATED BY INTUITIVE SURGICAL INC. (ISI) FAILURE ANALYSIS (FA). FA WAS ABLE TO REPLICATE THE REPORTED FAILURE BY INSTALLING THE TOUCH SCREEN ON AN IN-HOUSE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM. THE TOUCH SCREEN FAILED TO POWER ON DUE TO A BAD POWER SUPPLY. A VISUAL INSPECTION OF THE TOUCH SCREEN REVEALED SCRATCHES ON THE FRONT BEZEL AND SCREEN. ON (B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE. THE CSR INDICATED THAT THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE AFTER ANESTHESIA HAD BEEN ADMINISTERED TO THE PATIENT. THE SURGICAL PROCEDURE WAS RESCHEDULED AND COMPLETED SUCCESSFULLY ON (B)(6) 2013. NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE REPORTED. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT, AN OR NURSE. THE INITIAL REPORTER INDICATED THAT THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE SINCE THE TOUCH SCREEN ON THE VSC AND THE EXTERNAL MONITORS WERE NOT WORKING. SHE ALSO STATED THAT THE SURGICAL PROCEDURE WAS ABORTED AFTER THE PATIENT HAD BEEN ADMINISTERED ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED. THE INITIAL REPORTER DENIED THAT THE PATIENT DEVELOPED ANY COMPLICATIONS AFTER THE CASE WAS ABORTED BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT THE DA VINCI S SURGICAL PROCEDURE WAS ABORTED POST-ANESTHESIA AND INCISION PORT PLACEMENT AFTER ENCOUNTERING VISION ISSUES WITH THE TOUCH SCREEN ON THE VSC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE WHERE THE TOUCH SCREEN ON THE VISION SIDE CART (VSC) HAD NO POWER OR VIDEO. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE ON (B)(6) 2013. THE TSE INSTRUCTED THE SURGICAL STAFF TO CHECK THE POWER CORD ON THE BACK OF THE VSC AND TRANSFORMER AND TO ENSURE THAT THE CORD WAS FULLY SEATED. THE TSE ALSO ADVISED THE SURGICAL STAFF TO ENSURE THAT BOTH ENDS OF THE BLUE VIDEO CABLE WERE FULLY SEATED. PRIOR TO CONTACTING THE TSE, THE SURGICAL STAFF REPORTEDLY CYCLE POWERED ON THE SYSTEM. THE TSE ALSO ADVISED THE SITE TO PERFORM SCOPE ALIGNMENT FROM THE SURGEON SIDE CONSOLE (SSC). THE TSE DISPATCHED AN ISI FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE SITE. THAT SAME DAY ON (B)(4) 2013, A FSE VISITED THE SITE AND PERFORMED AN EVALUATION OF THE SYSTEM. THE FSE INDICATED THAT THE SURGEON MADE THE DECISION TO ABORT THE SURGICAL PROCEDURE DUE TO THE EXTERNAL MONITORS NOT WORKING. HOWEVER, THE FSE INDICATED THAT A NURSE INFORMED HIM THAT THE SYSTEM HAD BEEN MOVED OUT OF THE ROOM AND WAS RECENTLY BROUGHT BACK. ACCORDING TO THE FSE, THE SITE DID NOT CONTACT THE ISI TSE FOR TROUBLESHOOTING THE EXTERNAL MONITORS. THE FSE FOUND THE COMPOSITE VIDEO CABLE ON THE BACK OF THE VISION TOWER UNPLUGGED. AFTER THE FSE PLUGGED IN THE COMPOSITE VIDEO CABLE, THE EXTERNAL MONITORS WORKED WITHOUT ANY ISSUES. THE FSE ALSO FOUND A BROKEN COMPOSITE VIDEO CABLE ON THE LEFT CAMERA CONTROL UNIT (CCU). ACCORDING TO THE FSE, THE POWER SUPPLY FOR THE TOUCH SCREEN WAS ALSO NOT WORKING. THE FOLLOWING DAY ON AUGUST 7, 2013, THE REPAIRED THE SYSTEM BY REPLACING THE TOUCH SCREEN AND THE TOUCH SCREEN POWER SUPPLY. IN ADDITION, THE FSE REPLACED THE TOUCH SCREEN HARNESS. THE FSE THEN PERFORMED A SYSTEM VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440936 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE