BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16172583 · Received January 16, 2023

    Report

    Report Number
    2955842-2023-10111
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    December 16, 2022
    Report Date
    December 16, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED ERROR C-34 ON IESU, AN INVESTIGATION IS IN PROGRESS 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 COULD REPRODUCE THE REPORTED ERROR C-34 AND REPLACED THE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, EVALUATION/INVESTIGATION HAS NOT BEEN COMPLETED. THE COMPLAINT REGARDING ERROR C-34 WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. 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 ERRORS C-34 AND M-11 RELATED TO THE REPORTED COMPLAINT. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. COMPLAINTS ARE TRACKED. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE FSE CONFIRMED THE REPORTED ISSUE IN THE INVESTIGATION AND REPLACED THE IESU. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED AND MAY LEAD TO AN INJURY DUE TO THE PATIENT'S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPRODUCED THE REPORTED COMPLAINT. ERROR C-34 OCCURRED WHEN THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED ERROR C-34 OCCURRED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WHEN FIRING THE MONOPOLAR INSTRUMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ERRORS C-34 AND M-11 IN THE LOGS. THE TSE HAD THE CUSTOMER POWER CYCLE THE IESU, WHICH RESOLVED THE ISSUE. AFTER, THE CUSTOMER CALLED BACK AND STATED THAT THE ERROR REOCCURRED. THE TSE ADVISED THE CUSTOMER TO USE ANOTHER POWER OUTLET. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE ISSUE WAS NOT RESOLVED BY USING ANOTHER POWER OUTLET. THE CUSTOMER WAS ABLE TO CONTINUE TO USE IESU AFTER HARD POWER CYCLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750585 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.