BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21626234 · Received March 17, 2025

    Report

    Report Number
    2955842-2025-08651
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 21, 2025
    Report Date
    February 21, 2025
    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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS DUE TO THE FREE-STANDING FOOT PEDALS FAILING.

    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. FSE REPLACED THE FOOT PEDALS DUE TO RECURRING ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON 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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR M-12 OCCURRED ON VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU), AND FOOT PEDAL ACTIVATED ON ITS OWN. TSE CONFIRMED ERROR M-12 IN THE LOGS POINTING TO A POSSIBLE VISION SIDE CART (VSC) EXTERNAL FOOT PEDAL. TSE HAD CSR CONFIRM NOTHING WAS TOUCHING THE PEDALS AND ADJUST THE FOOT PEDALS. THE SURGEON WAS USING VESSEL SEALER (VS) INSTRUMENT WITH E-100 ELECTROSURGICAL UNIT (ESU), AND THERE WAS NO ISSUE WITH THE VS INSTRUMENT. SITE MIGHT DISCONNECT THE CABLES ON THE BACK OF VIO DV IESU TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 03/14/2025: THIS WAS CORRECTED BY DISCONNECTING THE PEDAL AFTER SEVERAL RE-STARTS. THIS WAS NOTED DURING A TRAINING SESSION, AS DESCRIBED IN THE ORIGINAL COMPLAINT, SO NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187064 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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