BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15728265 · Received November 4, 2022

    Report

    Report Number
    2955842-2022-15047
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 4, 2022
    Report Date
    October 4, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REPLACED THE ERBE (PART# 951300-03/SERIAL# (B)(4)) DUE TO THE U-02 ERROR. THE FSE ALSO REPLACED 1 MISSING FIBER RELEASE TAB (PART# 315111-02) AND A DAMAGED FIBER OPTIC DUST CAP ASSEMBLY (PART# 371814-01). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE GENERATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPRODUCED THE REPORTED ISSUE OF "ERBE U-02 ERRORS" THAT WERE PRESENT AS THE UNIT POWERED ON. THIS ERROR RELATES TO NO COMMUNICATION WITH THE SYSTEM CHECK MASTER. THE ERBE GENERATOR WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. NO SOFTWARE VERSIONS HAVE BEEN UPDATED TO THE UNIT. THE ERBE GENERATOR WILL BE RETURNED TO OTHER EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THE PROCEDURE LOG REVIEW WAS PERFORMED. PER THE REVIEW, THE LOGS CONFIRMED THAT THE CUSTOMER PERFORMED A UNILATERAL INGUINAL HERNIA PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY TSE. TSE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS 25913 RELATED TO AN INTEGRATED ELECTROSURGICAL UNIT (IESU) CHECK MASTER FAILURE. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE ELECTROSURGICAL GENERATOR UNIT (ESU) WAS REPLACED BY FIELD SERVICE ENGINEER (FSE) AFTER REPLICATING THE ISSUE. THE PROCEDURE SETUP PROCEEDED, AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH A THIRD-PARTY ESU. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. 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 CONVERSION/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) DURING CASE SETUP AND REPORTED THAT THERE WERE ERBE U-02 ERRORS. THE CUSTOMER ATTEMPTED TO POWER CYCLE, BUT THE ISSUE REMAINED. THE TSE WALKED THE CUSTOMER THRU THE U-02 WORK AROUND, BUT THE ERROR IMMEDIATELY RETURNED. THE CUSTOMER STATED THAT THEIR OTHER SYSTEMS ARE IN USE, BUT THEY DO HAVE A THIRD-PARTY GENERATOR ALREADY IN THE ROOM. THE CUSTOMER WAS CONTINUING WITH CASE SETUP AND WOULD LIKE THIS ISSUE RESOLVED AS SOON AS POSSIBLE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THIS OCCURRED DURING A UNILATERAL INGUINAL HERNIA PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A THIRD-PARTY FORCE TRIAD GENERATOR. THERE WAS NO PATIENT INJURY DUE TO THE ISSUE. NO IMAGES OR PATIENT DEMOGRAPHICS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491776 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A

    Patients

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