BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21674740 · Received March 24, 2025

    Report

    Report Number
    2955842-2025-11237
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 26, 2025
    Report Date
    February 26, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWER ON WITHOUT ERRORS. THERE WAS NO PATIENT INJURY, AND THE ISSUE HAPPENED NEAR THE END OF THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH 3 ARMS. PATIENT DEMOGRAPHIC INFORMATION WAS ASKED BUT NOT PROVIDED. THE UNIVERSAL SURGICAL MANIPULATOR (USM) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM ISSUE VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. SYSTEM LOGS SHOWN 32098 ERROR INDICATING BRUSHLESS MOTOR CONTROLLER FAULT ON THE USM AXES CONTROLLER MOTOR (ACM) PRINTED CIRCUIT ASSEMBLY (PCA). 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 COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION, BUT LOUD NOISE WAS HEARD FROM ACM FAN. ONCE TESTING WAS COMPLETED, THE ACM PCA WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FA CONCLUDED THAT THE ACM PCA WAS CONSISTENT WITH THE REPORTED EVENT AND IS THE POTENTIAL ROOT CAUSE FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE USM INVOLVED WITH THIS EVENT HAS BEEN RECEIVED, BUT THE FAILURE ANALYSIS TESTING HAS NOT YET BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    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 PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT ERROR 32098 OCCURRED ON ARM 4 AND IT COULD NOT BE RECOVERED AND RESTARTING THE SYSTEM DID NOT CLEAR THE ERROR. ACCORDING TO THE CUSTOMER, THE PROCEDURE HAD BEEN CARRIED OUT WITH THREE ARMS AFTER HE DISABLED ARM 4. THE TSE EXPLAINED THAT THE SYSTEM NEEDED TO BE CHECKED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727888 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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