BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18257881 · Received December 4, 2023

    Report

    Report Number
    2955842-2023-20815
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 8, 2023
    Report Date
    November 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS ANALYZED. THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. ON STARTUP THE UNIT DISPLAYED ERROR C-34. ERROR LOG SHOWS C-34, C-00 AND M-11. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN ISI TECHNICAL SUPPORT ENGINEER (TSE). INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: C-34. .

    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 PROSTATECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) WAS GIVING AN ERROR C-34 AT STARTUP. PRIOR TO CALLING TECHNICAL SUPPORT, THE CUSTOMER HAD RESTARTED THE ERBE AND REPLACED TWICE MONOPOLAR CAUTERY CABLE WITHOUT SUCCESS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND IDENTIFIED ERROR C-34 POINTING TO HIGH FREQUENCY VOLTAGE LOW. THE TSE ASKED THE CUSTOMER IF THERE IS A SOURCE OF MAGNETIC INTERFERENCE CLOSE BY. THIS CAN BE CAUSED BY OTHER ERBE. THE CUSTOMER CONFIRMED THERE IS NOT. THE TSE GUIDED THE SURGEON TO DISCONNECT THE POWER CORD FROM ERBE, TO WAIT 1 MINUTE AND TO RESTART THE ERBE, BUT ISSUE KEEPS COMING BACK. THE TSE ASKED THE CUSTOMER IF THE ERBE IS CONNECTED TO A DEDICATED AC OUTLET, BUT THE CUSTOMER WAS NOT SURE AND NOT EASY TO FOLLOW THE POWER CORD. THE TSE ASKED THE CUSTOMER IF THEY HAVE A SPARE ERBE AND HE CONFIRMED. TO ISOLATE THE ISSUE, THE TSE HAD SURGEON TO TAKE THE POWER CORD FROM SPARE ERBE AND TO CONNECT TO THE FAULTY ERBE TO ANOTHER WALL POWER SOCKET, BUT ISSUE PERSISTED. THE SURGEON AGREED TO CONTINUE WITH THE SPARE ERBE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048823 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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