BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3183191 · Received June 21, 2013

    Report

    Report Number
    2955842-2013-02266
    Event Type
    Other
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SITE'S SYSTEM LOGS AND FOUND 23020 AND 23034 SWITCH ERRORS RELATED TO THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THAT SAME DAY, AN ISI FIELD SUPPORT ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE RESOLVED THE ERROR MESSAGES BY REPLACING THE ECM. THE SYSTEM WAS THEN TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23020 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES ONE OF THE SWITCHES IN A SPECIFIC MANIPULATOR IS SHOWING INCONSISTENT SIGNALS ON TWO SWITCH LEADS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUT DA VINCI IN A RECOVERABLE SAFE STATE. ON (B)(4) 2013, ISI CONTACTED THE DA VINCI COORDINATOR AT THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE DA VINCI COORDINATOR INDICATED THAT THE ERROR MESSAGE BEGAN AT THE START OF THE SURGICAL PROCEDURE WHEN THE PSC WAS BEING DOCKED TO THE PATIENT. THE PATIENT WAS UNDER ANESTHESIA AND THE INCISION PORTS WERE ALREADY PLACED WHEN THE REPORTED ISSUE BEGAN. SINCE THE ERROR MESSAGE COULD NOT BE RESOLVED WITH TROUBLESHOOTING, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. THE DA VINCI COORDINATOR INDICATED THAT THE OPEN SURGICAL PROCEDURE WAS COMPLETED. SHE DID NOT KNOW THE PATIENT'S CURRENT STATUS. TO HER KNOWLEDGE, NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. THE ECM WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION FOUND AN CAMERA CLUTCH SWITCH FAULT. WHILE RUNNING THE ECM IN NORMAL MODE, AN ERROR 23034 WAS TRIGGERED AS SOON AS THE CAMERA CLUTCH WAS PRESSED. THE ARM WAS REPAIRED BY REPLACING THE CIRCUIT ASSEMBLY CONTAINING THE SWITCH. A VISUAL INSPECTION OF THE ECM REVEALED THAT THE FAULT WAS BEING TRIGGERED DUE TO A CONFIGURATION (CFG) CAP ASSEMBLY SWITCH THAT WAS FOUND TO BE NOT MAKING CONTACT PROPERLY. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING A RECURRING 23020 SYSTEM ERROR WITH THE DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A 23020 SYSTEM ERROR MESSAGE. IT WAS INDICATED THAT THE ERROR REOCCURRED EACH TIME THE RECOVER BUTTON WAS PRESSED AND THE SITE POWER CYCLED AND EMERGENCY POWERED OFF (EPO) THE PATIENT SIDE CART (PSC). HOWEVER, THE ERROR MESSAGE CONTINUED TO OCCUR. DUE TO THE RECURRING ERROR MESSAGE, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283873 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