BEUDAMED
    FDA Adverse Event Other Summary report: N

    IS2000 DAVINCI S SYSTEM

    MDR report key: 3124379 · Received May 22, 2013

    Report

    Report Number
    2955842-2013-01772
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. INTUITIVE SURGICAL INC. SENT FOLLOW UP QUESTIONS REGARDING THE ALLEGED ISSUE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A MALE PATIENT WHO WAS (B)(6) WAS GOING IN FOR A DA VINCI S THYMECTOMY PROCEDURE FOR THYMOM WITH MYASTHENIA GRAVIS ON (B)(6) 2013. REPORTER MENTIONED THAT THE DA VINCI S WAS TESTED AND SET UP THE EVENING BEFORE THE PROCEDURE AND NO ERROR MESSAGE OCCURRED DURING SET UP. ON (B)(6) 2013 PRIOR TO THE PROCEDURE, REPORTER MENTIONED THAT THEY STARTED THE DA VINCI S AND TESTED THE SYSTEM. APPROXIMATELY 45 MINUTES, THE VIDEO SCREEN TURNED BLACK; HOWEVER, THE SCREEN OF THE CONSOLE BAR SHOWED THE COLOR BAR. THE DA VINCI S WAS NOT DOCKED TO THE PATIENT AT ANY TIME AND NO PORT INCISIONS WERE PLACED ON THE PATIENT. DUE TO THE ALLEGED ISSUE, THE PHYSICIAN DECIDED TO CONVERT THE PROCEDURE TO OPEN. THE PATIENT WAS UNDER ANESTHESIA FOR ABOUT 30-45 MINUTES PRIOR TO THE PHYSICIAN'S DECISION TO CONVERT THE PROCEDURE TO OPEN. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS DURING THE OPEN PROCEDURE. THE PATIENT IS STILL ADMITTED IN THE HOSPITAL AND HIS STATUS IS NORMAL. THE VIDEO DIGITIZER UNIT IS BEING RETURNED BACK TO ISI FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE VIDEO DIGITIZER WAS RETURNED TO ISI FOR INVESTIGATION ON (B)(4) 2013. THE DIGITIZER WAS EVALUATED WITH THE FOLLOWING FINDINGS: FAILURE ANALYSIS (FA) WAS UNABLE TO REPLICATE THE INITIAL ISSUE THAT WAS REPORTED BY THE SITE. THE DIGITIZER POWERED UP WITH GOOD VIDEO ON BOTH EYES. THE SUBJECT DIGITIZER PASSED THE FOLLOWING TESTS: VIDEO CHECKED ON THREE STATIONS (VSC, SSC, PSC), FOCUS IN AND OUT, COMPOSITE AND SDI, TILE PRO, AND POWER CYCLE. THE LED ON THE BACK OF THE UNIT WAS PUSHED IN AND FA REPAIRED THE LED IN-HOUSE.

    Description of Event or Problem · 1

    THE SITE CONTACTED INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ON (B)(6) 2013 ALLEGING A LOSS OF BOTH VIDEO SIGNALS. THE REPORTER AT THE SITE MENTIONED THAT THE VIDEO SIGNAL WAS OK DURING THE SYSTEM START. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THERE WAS A DEFECTIVE DIGITIZER. THE POWER LED AT THE BACKSIDE OF THE DIGITIZER WAS OFF. TSE HAD THE REPORTER RESEAT ALL THE POWER CORDS AND RELATED CABLES; HOWEVER, ISSUE PERSISTED. DUE TO THE ALLEGED ISSUE THE SURGEON MADE A DECISION TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. REPORTER CONTACTED ISI AGAIN LATER ON THE SAME DAY AND MENTIONED THAT THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN SURGERY INSTEAD OF LAPAROSCOPIC SURGERY. REPORTER ALSO MENTIONED THAT THEY REPLACED THE CAMERA HEAD CABLE AND NOW THE VISION WORKS WELL; HOWEVER, MENTIONED THAT THE DIGITIZER POWER LED IS STILL NOT WORKING. BASED ON THE ALLEGED ISSUE THE FIELD SERVICE ENGINEER (FSE) REPLACED THE DIGITIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225850 IS2000 DAVINCI S SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES