BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20912385 · Received December 12, 2024

    Report

    Report Number
    2955842-2024-23154
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 18, 2024
    Report Date
    November 18, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE UNIT WAS THEN INSTALLED ONTO A PSC FIXTURE TEST PLATFORM (PFTP) WHERE SINE CYCLE WAS FOUND TO BE FAILING WITH 23087 ERROR (P1=5) ON THE CARRIAGE. DURING TESTING, THE INSTRUMENT STERILE ADAPTER (ISA) BOARD WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED EXPERIENCING INSTRUMENT ENGAGEMENT ISSUES WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 DURING THE FIRST TWO CASES OF THE DAY. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND 282 ERRORS FOR THE FIRST CASE; HOWEVER, LOGS FOR ANY SUBSEQUENT CASES THAT DAY WERE NOT AVAILABLE. THE CUSTOMER INDICATED THAT THEY ATTEMPTED TO REENGAGE THE STERILE ADAPTER FOR BOTH CASES, BUT THE DIALS WOULD NOT TURN. THEY NEEDED ONLY THREE USMS FOR THE PROCEDURES, SO THEY UTILIZED THE REMAINING THREE USMS. IN THE THIRD CASE, USM 2 AGAIN HAD ENGAGEMENT ISSUES, BUT THE CUSTOMER WAS ABLE TO RESEAT THE STERILE ADAPTER AND DID NOT ENCOUNTER ANY FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044764 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-57 N/A 00886874110720

    Patients

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