BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17091094 · Received June 8, 2023

    Report

    Report Number
    2955842-2023-16068
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 16, 2023
    Report Date
    May 16, 2023
    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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR (USM) UNABLE TO MOVE, 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. FSE CONFIRMED THE ERROR 319 POINTING TO THE ACC IN USM 1. NO ERRORS PRECEDED THIS TO SUGGEST IT WAS THE DISTAL SET UP JOINT (SUJ). THE FSE REPLACED THE 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 COMPLAINT REGARDING UNRESPONSIVE USM WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED, AND THE REPORTED FAILURE WAS REPLICATED AND CONFIRMED. UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED AN ERROR 319. UNIT WAS ALSO TESTED ON PFTP WHERE IT FAILED THE FIBER TEST FOR THE ROLLING LOOP. GOLDEN ROLLING LOOP FIBER CABLE WAS INSTALLED, AND THE FIBER TEST PASSED ON RETRY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHRECTOMY POST PORT PLACEMENT, THE UNIVERSAL SURGICAL MANIPULATOR (USM) ON THE PATIENT SIDE CART (PSC) WOULD NOT MOVE. ERROR 319 WAS POINTING TO THE ACC COMPONENT IN THE USM. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH 3 ARMS AND THE PORTS WERE PLACED WHEN THE ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251238 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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