BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19069038 · Received April 9, 2024

    Report

    Report Number
    2955842-2024-13149
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 11, 2024
    Report Date
    March 11, 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
    OR, US
    Reporter Occupation
    003

    Narratives

    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 WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE BUT THE FSE PROACTIVELY REPLACED THE ERBE GENERATOR. AFTER REPLACEMENT, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. M-11/C-00/M-B0/M-0B ERRORS ARE IN ERROR LOG. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE ERBE IS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT ERBE (ERBE) GENERATOR BIPOLAR ENERGY ACTIVATION WAS NOT WORKING. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). THE SYSTEM LOG CONFIRMED A RELATED ERROR FAULT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ENSURED PROPER USE OF INSTRUMENTS AND VERIFIED THAT THE ERBE GENERATOR INDICATED PROPER ARM ASSIGNMENTS FOR EACH INSTRUMENT. THE PROCEDURE WAS CONTINUED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE ROBOTICS COORDINATOR (ROCO) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED USING MONOPOLAR ENERGY ON THE SAME GENERATOR. DURING THE PROCEDURE, THE CSR PERFORMED TROUBLESHOOTING BY CHANGING THE INSTRUMENTS, VSC, AND CABLES, BUT TROUBLESHOOTING DID NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270084 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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