BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 24710031 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19044
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 27, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114742
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. FSE REPLACED THE AUXILIARY VIDEO BOARD (AVP) AND ENERGY SHIELD MONITOR (ESM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE AVP WAS ANALYZED AND WAS FOUND TO HAVE ELECTRICAL/FIBEROPTIC DEFECTS RESULTING IN THE COMPONENT NOT FUNCTIONING DURING TESTING. THE COMPLAINT WAS CONFIRMED BASED ON THE RESULTS OF THE INVESTIGATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FAILURE ANALYSIS FOR ESM HAS NOT BEEN COMPLETED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, ERROR 32209 OCCURRED. PRIOR TO CALLING TECHNICAL SUPPORT, CLINICAL SALES REPRESENTATIVE (CSR) POWER CYCLED SYSTEM BUT ERROR PERSISTED. ALL LEDS ON THE ENERGY SHIELD MONITOR (ESM) WERE FLASHING YELLOW. INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) ASKED CSR TO POWER OFF THE SYSTEM AND GUIDED CSR THROUGH TO VERIFY THE INTEGRITY OF ALL CONNECTIONS ON ESM AND RELATED CONNECTIONS ON CORE AND VIDEO PROCESSOR (VP). CSR VERIFIED ALL CONNECTIONS WERE SEATED PROPERLY. TSE ALSO GUIDED CSR TO VERIFY CONNECTIONS BETWEEN ERBE AND ESM, ALL VERIFIED. TSE HAD THE CSR TOGGLE CIRCUIT BREAKER ON ESM. AFTER RESTART SYSTEM STARTED UP WITH SAME ERROR 32209 AND ALL LEDS ON ESM WERE STILL FLASHING YELLOW. SYSTEM WAS NOT CONNECTED TO ONSITE DURING CALL, SO NO RELEVANT LOGS COULD BE OBTAINED. CSR INFORMED TSE THAT THE PROCEDURE WILL BE PERFORMED AS AN OPEN SURGERY DUE TO THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143053 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-50 N/A 00886874114742

    Patients

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