BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16893087 · Received May 9, 2023

    Report

    Report Number
    2955842-2023-12976
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF GETTING ¿REPEATED ERROR 23138¿. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED/TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE, WHERE IT CONFIRMED AND REPLICATED (ERROR 23138 ON DEGREE OF FREEDOM (DOF) 5). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED 23138 ERRORS ON DOF 5. THE UNIT ALSO FAILED SINE CYCLE TEST WITH ERROR 23138 ON THE CARRIAGE DOF 5. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP), AND PASSED DIRECTION TEST, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SENSOR CHECK, FRICTION TEST, CARRIAGE FRICTION TEST, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. THE INSTRUMENT STERILE ADAPTER (ISA) BOARD, DOF 5 GEARBOX, AND DOF 5 ROTOR WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. THE PROBABLE ROOT CAUSE OF THIS REPORTED FAILURE IS ATTRIBUTED TO COMPONENT FAILURE. THE COMPLAINT REGARDING REPEATED 23138 WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATED THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE REPORTED REPEATER ERROR 23138 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THEREFORE, THE FSE REPLACED USM 4 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM HAS BEEN RETURNED TO ISI FOR EVALUATION. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED AFTER THE START OF THE PROCEDURE DUE TO A REPEATED RECOVERABLE ERROR. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE 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/ABORTION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED THAT THERE WAS A RECOVERABLE ERROR THAT KEPT COMING BACK. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR WITH A RESTART BUT THE ERROR RETURNED AFTER DOCKING. THE TSE ADVISED THE CUSTOMER THAT FIELD ENGINEER (FE) VISIT WAS LIKELY REQUIRED. THE CUSTOMER OPTED TO BRING IN ANOTHER PATIENT SIDE CART (PSC) TO COMPLETE THE CASE AS THE SURGEON NEEDED 4 ARMS. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT WAS CONFIRMED TO HAVE TAKEN PLACE ON (B)(6) 2023 DURING A RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY. THE PROCEDURE WAS CONFIRMED TO HAVE BEEN COMPLETED ROBOTICALLY WITH THE SECOND PATIENT SIDE CART WITH NO INJURY TO THE PATIENT. PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725556 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES.