BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 19858211 · Received July 29, 2024

    Report

    Report Number
    2955842-2024-17400
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER FAILURE ANALYSIS INVESTIGATION AND IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD AND REPLICATED IN-HOUSE. THE LOGS RECORDED ERROR 282 POINTING TO THE CARRIAGE RFID. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITH NO TRIGGERED ERRORS. THE UNIT WENT THROUGH TESTING ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CARRIAGE SWITCHES TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, MULTIPLE INSTRUMENTS WERE NOT RECOGNIZED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. PRIOR TO THE CALL, THE CUSTOMER ALREADY REPLACED THE STERILE ADAPTER (SA) AND CHECKED CORRECT SEATING. THE SURGICAL TEAM TRIED MULTIPLE SA AND INSTRUMENTS ON USM 3 WHICH WORKED FINE ON OTHER USMS. THE POGO PINS WERE FREE TO MOVE. THE INSTRUMENTS WERE STILL NOT RECOGNIZED ON USM 3. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY AND WITH A DELAY OF LESS THAN 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE HAD TO COMPLETE THE PROCEDURE WITH 3 ARMS SINCE THE USM 3 DID NOT RECOGNIZE ANY INSTRUMENTS. THERE WAS NO PATIENT HARM.

    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
    244963 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A

    Patients

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