BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 24709910 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19175
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 24, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110737
    PMA / PMN Number
    K123463
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 GENERIC CART CONTROLLER (GCC), PATIENT BACK PLANE (PBP) PRINTED CIRCUIT ASSEMBLY (PCA), AUXILIARY POWER BOARD (APB) PCA, POWER SUPPLY AND GENERIC POWER DISTRIBUTOR (GPD) TO SOLVE THE REPORTED ISSUES. 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. THE GCC WAS ANALYZED AND IN ARTEMIS, ERROR 90 WAS FOUND INDICATING THAT THE FAULT OCCURRED IN THE FIELD. THE GCC WAS INSTALLED ON THE GOLDEN SYSTEM. UPON POWER ON, GCC WAS NOT VISIBLE ON LAPTOP APP. THERE WAS RED LED LIGHT ON GCC, THE GCC HAS FAILED. THE PBP PCA WAS ANALYZED AND DURING VISUAL INSPECTION, NO ISSUES WERE FOUND THAT IS RELATED TO THE REPORTED ISSUE. THE UNIT WAS INSTALLED AND TESTED INTO A GOLDEN PCA SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE SYSTEM STARTED UP WITHOUT ANY ERROR. ALSO, RAN 10X POWER CYCLE WITH THIS PART, ALL PASSED. EXERCISING ALL ARMS WITH NO ISSUE. THEN, THE UNIT REMAINED ON THE TEST SYSTEM FOR HOUR. THE APB PCA WAS ANALYZED AND INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THEN, THE GOLDEN SYSTEM WAS SET TO RUN 10 MINUTES, 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. ONCE THE TESTING WAS COMPLETED AFTER COMPLETED SYSTEM THE PATIENT SIDE CART (PSC) SYSTEM NO PROBLEM. THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE POWER SUPPLY WAS ANALYZED AND INSTALLED ONTO THE GOLDEN SYSTEM AND COMPLETED PROGRAM WITH NO PROBLEM, CONTINUED PERFORMANCE WAS SET TO 10 POWER CYCLES AND SITTING IDLE FOR 1 HOUR. AFTER TESTING 10X CYCLES THERE WAS NO ERROR. ONCE THE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE GPD WAS ANALYZED AND UPON VISUAL INSPECTION, FOUND THE COMPONENTS U12 WAS BURN. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START - PRE-ANESTHESIA OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT 90. CUSTOMER DID A SYSTEM HARD POWER CYCLE AND NORMAL POWER CYCLE MULTIPLE TIMES, BUT ISSUE REMAINED. TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED TO RESET CORE FROM THE BACK BUT ISSUE STILL REMAINED. TSE REVIEWED LOGS AND FOUND ISSUE WITH PATIENT CART CONTROLLER (PCC) AND GENERIC POWER DISTRIBUTOR (GPD) BOARD. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601921 DAVINCI SI PATIENT SIDE CART, 4-ARM, RECERTIFIED NAY INTUITIVE SURGICAL, INC 380675-04 N/A 00886874110737

    Patients

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