BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20876931 · Received December 9, 2024

    Report

    Report Number
    2955842-2024-22917
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MASTER TOOL MANIPULATOR (MTM) WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 25521 ERROR WAS TRIGGERED INDICATING FAULT ON THE EMBEDDED SERIALIZER MASTER BASE (ESMB) PCA AXIS 1, REPLICATING THE REPORTED EVENT. THE MTM WAS THEN INSTALLED ONTO A PATIENT CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE SINE CYCLE TEST. ONCE TESTING WAS COMPLETED, THE ESMB PCA WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. ROOT CAUSE IS ATTRIBUTED TO THE ESMB PCA COMPONENT.

    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 THE MASTER TOOL MANIPULATOR (MTM). ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. HOWEVER, FAILURE ANALYSIS IS NOT COMPLETE.

    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 RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE TECHNICAL SERVICE ENGINEER (TSE) FOR PHONE ASSISTANCE DUE TO ERROR 25521. THE TSE RECOMMENDED FOR THE CUSTOMER TO PERFORM A HARD POWER CYCLE AND TO CHECK THE BLUE FIBER CONNECTION. THE REPORTED EVENT WAS TEMPORARILY RESOLVED BUT REAPPEARED. TSE NOTED THAT ERROR 25521 INDICATED A COMMUNICATION INNER SYSTEM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95385 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-27 N/A 00886874110744

    Patients

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