BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21122791 · Received January 10, 2025

    Report

    Report Number
    2955842-2024-24059
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 16, 2024
    Report Date
    December 16, 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
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON AN IN-HOUSE SYSTEM AND TRIGGERED NO ERRORS. THE USM WAS ALSO TESTED ON THE PATIENT FIXTURE TEST PLATFORM AND PASSED ALL TESTS. UPON FURTHER INVESTIGATION THERE WAS NO FLUID INTRUSION OR PHYSICAL DAMAGE. THE ISI VIRTUAL SUPPORT SHOWS ERROR 22021 IS GRIP CALIBRATION OR INSERTED TOOL ISSUE. REMOTE FE ALSO SHOWS ERROR 22021. THE TOP PLATE, DOF¿S 7/8 GEARBOXES & ROTORS ARE CONSISTENT WITH THE REPORTED EVENT.

    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 DID CONFIRM INSTRUMENT ENGAGEMENT ISSUES ON THE SYSTEM. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED AND THE LOG REVIEW WAS INCONCLUSIVE, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW.

    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 TONSILLECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 DID NOT RESPOND AFTER THE PROGRASP FORCEPS (PF) INSTRUMENT WAS INSTALLED. THE SITE RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). BEFORE THE PHONE CALL, THE SITE REPLACED PF INSTRUMENT WITH NEW INSTRUMENTS, RESEATED STERILE ADAPTER (SA) AND REPLACED INSTRUMENT ARM DRAPE, BUT THE ISSUE WAS NOT RESOLVED. THE SITE CONFIRMED THAT THE INSTRUMENTS WORKED NORMALLY ON THE OTHER USM ARMS. THE TSE FOUND ERROR 2021 IN THE LOGS POINTING TO A GRIP CALIBRATION FAILURE ON USM 4. THE SITE DISABLED USM 4 AND CONTINUED THE PROCEDURE WITH THE REMAINING THREE ARMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324913 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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