BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21089050 · Received January 7, 2025

    Report

    Report Number
    2955842-2024-24015
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 12, 2024
    Report Date
    December 12, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ELECTRO SURGICAL GENERATOR UNIT (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 TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (C-34 ERROR AND MONOPOLAR NOT WORKING) WAS CONFIRMED AND REPRODUCED ON ERBE CONNECTED TO SYSTEM. LOGS CONFIRMING THE FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION:(THE FROM TOP OF THE BEZEL IS CRACKED ON BOTH SIDES. ) (C-34 ERROR DURING START AND MONO COAG ACTIVATION) ERBE UNIT THAT WAS PLACED ON A SYSTEM AND WAS RUN IN NORMAL MODE. ( MEASUREMENT VALUE FOR HF VOLTAGE TOO SMALL WITH ON) FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    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. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS BEEN RECEIVED AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT TO REPORT THAT MONOPOLAR ENERGY WAS NOT WORKING AND A C-34 ERROR WAS BEING PRESENTED BY THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE CUSTOMER ADVISED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY'D TRIED A NEW MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND GREEN CORD WITH NO CHANGE. THE IESU HAD ALSO BEEN POWER CYCLED WITHOUT RESOLUTION. AS A RESULT, THE CUSTOMER ELECTED TO CONNECT A COVIDIEN ESU AND UTILIZED IT FOR MONOPOLAR ENERGY. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALLY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THE GENERATOR WAS EXCHANGED OUT FOR THE COVIDIEN ESU AS A RESULT OF THE ISSUE. PER THE SURGEON, THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011900 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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