BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4027809 · Received August 21, 2014

    Report

    Report Number
    2955842-2014-05111
    Event Type
    Other
    Date Received
    August 21, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ILLUMINATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED ISSUE. AN ERROR CODE 297 WAS GENERATED WHEN THE UNIT WAS INSTALLED IN A PCA SYSTEM AND THERE WAS NO POWER FROM THIS UNIT. THERE WAS NO LAMP MODULE INSIDE THIS UNIT. AFTER FURTHER REVIEW OF THIS COMPLAINT, ISI CONSIDERS THIS CASE AS NON-REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE REPORTED CONVERSION OF THE DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY DOES NOT MEET ISI'S CRITERIA FOR A SERIOUS INJURY AND IS NOT CONSIDERED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. BASED ON THIS INFORMATION, THIS MDR REPORT IS BEING RETRACTED.

    Additional Manufacturer Narrative · 1

    THE ILLUMINATOR HAS BEEN REQUESTED BACK FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ILLUMINATOR IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2014 AND CONFIRMED THE REPORTED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED ERROR CODES 297 AND 48238, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY SURGICAL PROCEDURE, THE ILLUMINATOR WENT OFF AND THE DA VINCI SURGICAL SYSTEM DISPLAYED AN ERROR CODE 297 AFTER RESTARTING THE SYSTEM. SYSTEM ERROR CODE 297 APPEARS WHEN THE SYSTEM DETECTS THAT AN ELECTRONIC COMPONENT WAS REPORTING AN INCORRECT CONFIGURATION. UPON DETERMINING THIS CONDITION, THE SYSTEM RECORDS THE FAULT AND TRANSITIONS TO A SAFE STATE. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE SURGICAL STAFF ALSO ENCOUNTERED AN ERROR CODE 48238 WHEN THE COMMUNICATION TO THE ILLUMINATOR WAS DISCONNECTED. AN ERROR CODE 48238 INDICATES AN ILLUMINATOR COMMUNICATIONS FAILURE. THE ERROR CODE APPEARS WHEN COMMUNICATIONS WITH THE ILLUMINATOR HAVE BEEN LOST OR INTERRUPTED FOR A SIGNIFICANT PERIOD OF TIME. DUE TO THE REPORTED ISSUES, THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) GATHERED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR REGARDING THIS COMPLAINT. THERE WERE NO REPORTED SYSTEM ERRORS DURING THE SETUP OF THE DA VINCI SURGICAL SYSTEM. THE ILLUMINATOR ISSUE OCCURRED APPROXIMATELY 20 MINUTES INTO THE DA VINCI PROCEDURE WHEN THE SURGEON WAS ISOLATING THE TUMOR. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUE SINCE THE VISION SIDE CART AND THE SURGEON SIDE CONSOLE DID NOT HAVE ANY VIDEO. THE OPEN PROCEDURE WENT WELL; HOWEVER, AFTER 5-6 HOURS THE PATIENT HAD STOPPED BREATHING FOR AN UNKNOWN REASON. ACCORDING TO THE DISTRIBUTOR, THE PATIENT IS CURRENTLY IN STABLE CONDITION; HOWEVER, HIS DISCHARGE DATE WILL DEPEND UPON HIS STATUS. ON THE SAME DAY OF THIS EVENT, AN ISI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE ILLUMINATOR. THE DA VINCI SURGICAL SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE AFTER THE ILLUMINATOR WAS REPLACED. THE ILLUMINATOR WILL BE SENT BACK TO ISI FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507528 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other