BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 25029298 · Received April 29, 2026

    Report

    Report Number
    2955842-2026-23086
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE ADVANCED PROCESSOR TO RESOLVE THE ISSUE. SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ADVANCED PROCESSOR ERROR 66200 OCCURRED. THE CIRCULATING NURSE STATED THAT THE SURGEON UNDOCKED THE SYSTEM AND CONTINUED THE PROCEDURE WITHOUT THE ROBOT BEFORE CONTACTING TECHNICAL SUPPORT. BEFORE THE CALL, THE NURSE HAD ALREADY POWER CYCLED THE SYSTEM TWICE, BUT THE ERROR PERSISTED. AFTER REVIEWING THIS INFORMATION, TECHNICAL SUPPORT REQUESTED THAT THE ISSUE BE FURTHER TROUBLESHOT ONSITE, AND IT WAS NOTED THAT THE CUSTOMER DECLINED TO USE THE SYSTEM FOR SUBSEQUENT PROCEDURES. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC APPROACH WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169926 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-46 N/A 00886874119662

    Patients

    Seq Age Sex Outcome Treatment
    1