BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691680 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18433
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    November 20, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE FSE REPLACED PARTS TO CORRECT 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. THE PATIENT SIDE CART (PSC) COMMON COMPUTE CONTROLLER (CCC) WAS ANALYZED AND FOUND THAT IN VIA LIGHTHOUSE LOG REVIEWS: ERROR 31089 AURORA LINK ERROR. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PSC CCC WAS INSTALLED INTO THE GOLDEN SYSTEM WHICH TRIGGERED THE REPORTED ERROR, INDICATING FAULTS ON THE FIREFLY FIBER OPTIC CABLE (FF3) ON THE CCC. THE FIREFLY OPTIC CABLE WAS REPLACED WITH A KNOWN GOOD CABLE USING AN ABA PROCEDURE. THE PSC CCC FUNCTIONS AS EXPECTED, BUT WHEN CABLE IS SWITCHED BACK TO THE ORIGINAL FIREFLY OPTIC CABLE IT FAILS. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FIELD SERVICE ENGINEER (FSE) CALLED IN FOR GUIDANCE FOR ORDERING 375031 FOR PATIENT SIDE CART (PSC) PIGTAIL BUT RECEIVED THE 375030 TOWER PIGTAIL WHICH IS LONGER. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THEM THAT THEY'RE NOT INTERCHANGEABLE. TSE REVIEWED LOGS AND THINKS IT MIGHT BE MORE OF A PSC COMMON COMPUTE CONTROLLER (CCC) ISSUE. BUT FSE WILL REPLACE IT AND THEN REORDER THE 375031 AND REPLACE IT IF NEEDED. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556470 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 00886874119716

    Patients

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