BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21029053 · Received December 27, 2024

    Report

    Report Number
    2955842-2024-23655
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 2, 2024
    Report Date
    December 2, 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
    CH
    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 BURNING SMELL WAS FROM THE INTEGRATED ELECTROSURGICAL UNIT (IESU) NOT THE VISION SIDE CART (VSC) OTHER COMPONENTS. THE VSC WORKED FINE, BUT THE IESU COULD NOT WORK ANYMORE. THE CUSTOMER HAD NO MAINTENANCE SERVICE AND REFUSED TO PERFORM REPAIR. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE VISION SIDE CART (VSC) HAD ERROR C-48/M-11 DURING ENERGY ACTIVATION INTERMITTENTLY. THE SITE SWAPPED TO A 3RD-PARTY GENERATOR TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGICAL PORTS WERE PLACED PRIOR TO THE ISSUE BEING IDENTIFIED, AND SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM DID NOT INITIALLY POWER ON WITHOUT ERRORS AND ISI TECHNICAL SUPPORT WAS CONTACTED FOR TROUBLESHOOTING WITH FULL TROUBLESHOOTING COMPLETED. THE SITE SWAPPED TO A 3RD-PARTY GENERATOR AND COMPLETED THE PROCEDURE SUCCESSFULLY WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762882 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-61 N/A 00886874110898

    Patients

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