BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3620041 · Received February 10, 2014

    Report

    Report Number
    2955842-2014-00730
    Event Type
    Other
    Date Received
    February 10, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PSM 2 WAS REQUESTED BACK FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE PSM2 IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE FIELD SERVICE ENGINEER REPLACED THE PSM 2 AND THE ISSUE WITH ERROR CODES WAS RESOLVED. THE SYSTEM TESTED TO ORIGINAL EQUIPMENT MANUFACTURER SPECIFICATIONS. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND CONFIRMED THE ERROR CODES. THE COMPLAINT IS BEING REPORTED SINCE THE SURGEON DECIDED TO CONVERT THE DA VINCI PROCEDURE TO OPEN PROCEDURE DUE TO THE ALLEGED ERROR CODE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS VERIFIED THE REPORTED ERRORS IN THE SYSTEM LOGS; HOWEVER, WAS UNABLE TO DUPLICATE THE FAULT CONDITION. THE PSM2 PASSED VISUAL AND FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE HAD OBTAINED A NON RECOVERABLE ERROR CODE 23013 ON THE PATIENT SIDE MANIPULATOR(PSM) 2 AXIS 6. AN ERROR 23013 MEANS THE POTENTIOMETER AND ENCODER ARE NOT TRACKING EACH OTHER PROPERLY; THE PROBLEM IS USUALLY CAUSED BY EITHER THE POTENTIOMETER OR THE ENCODER (OR ASSOCIATED WIRING) BEING FAULTY. INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE SITE TO POWER DOWN THE SYSTEM AND MOVE AXIS 6 AND ALL OTHER AXES A FEW TIMES. THE TSE ASKED THE SITE TO COMPLETELY TURN OFF THE SYSTEM USING EMERGENCY POWER OFF (EPO) SWITCH AND DISCONNECT THE AC WALL POWER AT PATIENT SIDE CART (PSC) WHILE MOVING THE AXES. THE SITE TRIED TO RESTART THE SYSTEM; HOWEVER, WAS UNSUCCESSFUL. THE TSE TRIED MULTIPLE TIMES TO RECOVER THE ERROR MESSAGE; HOWEVER, WAS UNSUCCESSFUL. DUE TO THE ALLEGED ISSUE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88346 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1