BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20503198 · Received October 22, 2024

    Report

    Report Number
    2955842-2024-20775
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 26, 2024
    Report Date
    September 26, 2024
    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
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTEGRATED ELECTROSURGICAL UNIT (IESU) INVOLVED IN THIS EVENT WAS RETURNED AND TESTED ON AN IN-HOUSE SYSTEM. ERROR C-34 WAS CONFIRMED AND REPRODUCED. THE REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE ERBE TO RESOLVE THE C-34 ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE SITE TO RETURN THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (ERBE) HAD A C-34 ERROR. THE CUSTOMER HAD ALREADY REPLACED THE INSTRUMENT, ENERGY CABLE, AND REBOOTED THE ERBE BUT THE ISSUE REMAINED. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED THE REPORTED ERROR ALONG WITH M-11 AND M-18 ERRORS. THE TSE WALKED THE CUSTOMER THROUGH POWERING OFF THE ERBE, DISCONNECTING THE POWER CABLE, AND POWERING ON THE ERBE TO RESTORE POWER. THE ISSUE RETURNED AFTER A SHORT TIME. THE CUSTOMER DID NOT HAVE A BACKUP GENERATOR AVAILABLE, SO THEY WOULD PROCEED WITH THE PROCEDURE BY USING A SYNCHROSEAL INSTRUMENT ON THE E-100. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE TSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: FROM THE LOGS, THE SYSTEM POWERED ON WITHOUT ERRORS. START OF FOLLOWING (WHEN SURGEON STARTED TO USE ONE INSTRUMENT) WAS AT 09:28 AND FIRST ERROR MESSAGE FROM 10:45. THE TOOL LIST SHOWED THAT THE SYNCHROSEAL HAS BEEN USED. END OF PROCEDURE WAS AT 12:15. NO OTHER INFORMATION WAS AVAILABLE. THE CUSTOMER DID NOT CALL BACK TO LET THE TSE KNOW WHAT HAPPENED AFTER THEY STARTED TO USE THE E-100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280109 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES