BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20738554 · Received November 20, 2024

    Report

    Report Number
    2955842-2024-22185
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 28, 2024
    Report Date
    October 28, 2024
    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
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND THE LOG RECORDED ERROR 32097 COUPLED WITH ERROR 1126 POINTING DOWNSTREAM FROM THE AXES CONTROLLER ARM (ACA). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED ERROR 1126. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE FIBER TEST. TROUBLESHOOTING WAS PERFORMED WITH A GOLDEN CLOCKSPRING FIBER INSTALLED TO VERIFY FAILURE. NO SIGNS OF DAMAGE WERE OBSERVED DURING VISUAL INSPECTION. THE CLOCKSPRING WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    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. THE FSE FOUND THE SYSTEM IN A FAULTED STATE. THE ERROR WAS 32097 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AND REPLACED THE USM2. THE SYSTEM WAS VERIFIED AND WAS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 REPORTED RECOVERABLE FAULTS. THE SYSTEM LOGS CONFIRMED REPEATED FAULTS POINTED TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AXES CONTROLLER, MOTOR (ACM). AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WOULD FOLLOW UP. AT THIS TIME, IT IS UNKNOWN IF THE CUSTOMER CONTINUED THE PROCEDURE IN ITS ORIGINAL CONFIGURATION. THE PROCEDURE WAS DELAYED FOR LESS THAN 15 MINUTES AND COMPLETED AS PLANNED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2458577 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES