BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 14898736 · Received July 3, 2022

    Report

    Report Number
    2955842-2022-12768
    Event Type
    Malfunction
    Date Received
    July 3, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE RECONNECTED THE BLUE FIBER CABLES AND THE SYSTEM CAME UP WITH NO ERRORS. THE GIGABIT CONNECTION WAS DOUBLE CHECKED, AND THE READINGS WERE ALL WITHIN SPECIFICATION. MULTIPLE POWER CYCLES WERE PERFORMED WITH NO ERRORS. THE SYSTEM WAS THEN WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED. NO PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS AS A RESULT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TECHNICAL SUPPORT WHEN THE CUSTOMER CALLED FOR TROUBLESHOOTING ASSISTANCE. INVESTIGATION REVEALED AN ERROR 54 INDICATING THAT THE MASTER SUPERVISORY CONTROLLER (MSC) RECEIVED THE POWER WARNING ON THE FIBER INSTANCE 2 (2ND DOWN FROM TOP PORT ON CORE) AND AN ERROR 55 INDICATING THAT THE MSC RECEIVED THE POWER ALARM ON THE FIBER INSTANCE 2 (2ND DOWN FROM TOP PORT ON CORE) RELATED TO THE REPORTED COMPLAINT. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE (B)(6) 2022 ON SYSTEM SK4259. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO NON-RECOVERABLE ERRORS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - BENIGN SURGICAL PROCEDURE, THE SYSTEM ENCOUNTERED A NON-RECOVERABLE 252 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND FOUND MULTIPLE FIBER RELATED ERRORS POINTING TO THE SECOND PORT FROM THE TOP OF THE CORE. THE CUSTOMER BEGAN TO UNDOCK AND THE TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CUSTOMER TO POWER DOWN THE SYSTEM. ONCE ALL POWER BUTTONS WERE CONFIRMED AMBER, THE CUSTOMER CHECKED THE FIBER CABLES ENSURING THEY WERE SEATED PROPERLY. THE SYSTEM WAS THEN POWERED BACK UP AND AN ERROR 31243 WAS PRESENT. THE CUSTOMER THEN PERFORMED A HARD POWER CYCLE AND THEN POWERED BACK UP. HOWEVER, AN ERROR 23 RETURNED. THE CUSTOMER NOTICED EARLIER THAT THE SECOND PORT FROM THE TOP HAD A RED LED AND WAS NOW GREEN. THE TSE ASKED CUSTOMER IF THEY HAD A SPARE FIBER CABLE AND THEY WERE NOT SURE. THE TSE ASKED IF THEY WERE ABLE TO DISCONNECT THE FIBER CABLE AND REPLACE WITH ONE OF THE SURGEON SIDE CONSOLE (SSC) FIBERS. HOWEVER, THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472191 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES