BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 23514448 · Received November 10, 2025

    Report

    Report Number
    2955842-2025-44621
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114735
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    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 EVENT. THE FSE CONFIRMED THE ERRORS POINTING TO THE REMOTE ARM CONTROLLER (RAC) BOARD ON THE CONSOLE AND REPLACED THE RAC 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 (FA). FA CONFIRMED THE REPORTED COMPLAINT VIA SYSTEM LOGS. VISUAL INSPECTION FOUND NO ISSUES THAT WERE RELATED TO THE REPORTED ISSUE. THE RAC WAS ANALYZED AND FOUND TO HAVE THE 307 ERROR WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE PROBABLE ROOT CAUSE IS DUE TO AN ISSUE WITH THE RCM. THIS ISSUE CAN BE RESOLVED BY CONTACTING ISI AND HAVING THE FSE REPLACE THE RAC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED TO REPORT THAT THE SYSTEM REPEATEDLY POWERED UP WITH NON-RECOVERABLE FAULT ERRORS 252 AND 307. ALTHOUGH THE LOGS WERE INCOMPLETE WHEN THE CALL ENDED, THE AVAILABLE ENTRIES INDICATED ERROR 307 ON THE SURGEON SIDE CONSOLE (SSC), SUGGESTING A POSSIBLE ISSUE WITH REMOTE ARM CONTROLLER (RAC) 1. THE CUSTOMER MENTIONED HE HAD TRIED INSTALLING THE SIM BACKPACK ON THE SSC A FEW DAYS EARLIER, BUT PERSISTENT ERRORS PREVENTED ITS USE, SO HE HAD ABANDONED FURTHER ATTEMPTS UNTIL TODAY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER THROUGH MULTIPLE POWER CYCLES, BUT THE ERRORS PERSISTED, LEADING THE SITE TO CONVERT TO ANOTHER DA VINCI SYSTEM FOR THEIR PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615414 DA VINCI SP SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380940-33 N/A 00886874114735

    Patients

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