BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21417093 · Received February 19, 2025

    Report

    Report Number
    2955842-2025-01580
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 25, 2025
    Report Date
    January 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM)2 WAS ANALYZED AND FOUND TO HAVE ERROR 307. IN SYSTEM ERROR LOGS, THE ERROR 307 WAS FOUND INDICATING THAT A NODE CONFIGURED TO BE PRESENT DID NOT RESPOND ON THE USM AXES CONTROLLER CARRIAGE (ACC) NODE, CONFIRMING THE FAULT OCCURRED IN THE FIELD. ACCOMPANYING THIS ERROR WAS ALSO 319 INDICATING A NODE CONFIGURED TO BE PRESENT DID NOT RESPOND DURING SYSTEM START UP ON USM ACC NODE. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 307 AND 319 WERE TRIGGERED INDICATING FAULT ON THE ACC NODE, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE CHECK ALL BOARDS TEST WAS FOUND TO BE FAILING ON THE AXES CONTROLLER SPAR (ACS) DOWNSTREAM. THE UNIT ALSO FAILED FIBER TEST ON THE ACS DOWNSTREAM. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA TESTED AND WERE VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IN THIS CASE IS ATTRIBUTED TO THE ROLLING LOOP FIBER.

    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. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM2) DUE TO NON-RECOVERABLE ERROR 307. SYSTEM INSPECTED, TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE USM. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT 307, POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM2), OCCURRED ON THE SYSTEM. THE CUSTOMER TRIED HARD POWER CYCLING THE SYSTEM, BUT THE ISSUE REMAINED. THE CUSTOMER THEN DISABLED USM2 AND PROCEEDED WITH THE CASE WITH THREE USMS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM POWERED ON WITHOUT ANY ISSUES OR ERRORS. THE CUSTOMER CONFIRMED THAT THE CASE WAS COMPLETED WITH THE THREE REMAINING ARMS AFTER ARM 2 WAS DISABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360077 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

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