BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25051867 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23505
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 21, 2026
    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
    PL
    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. FSE REPLACED THE REDUNDANT POWER TRAY ASSEMBLY (RPTA) DUE TO ERROR 86. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE RPTA FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED, IF ADDITIONAL INFORMATION IS OBTAINED. PROBABLE CAUSE OF ERROR 86 POINTS TO POWER DISTRIBUTION BOARD ADC FAULT - THE MSC SAW AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM WAS PRESENTING NON-RECOVERABLE FAULT 86. PRIOR TO CALLING TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER HAD POWER CYCLED THE SYSTEM SEVERAL TIMES, WITH ISSUE PERSISTING. AS SYSTEM WAS ONSITE, TSE COULD REVIEW THE LOGS AND FOUND THAT IT WAS POINTING TO A VOLTAGE ISSUE INSIDE OF THE VISION SIDE CART (VSC) AND INFORMED CUSTOMER THAT IT WAS NOT RECOMMENDED TO USE THE SYSTEM IN THIS STATE, THOUGH IT WOULD BE A SURGICAL DECISION IF THEY DECIDED TO. THE CUSTOMER WOULD NOT PROCEED WITH SURGERY AS THERE WAS NO PATIENT IN THE THEATRE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207273 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1