BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 16972003 · Received May 22, 2023

    Report

    Report Number
    2955842-2023-14431
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 19, 2021
    Report Date
    April 19, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    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 REPORTED COMPLAINT WAS REPRODUCED DURING FIELD EVALUATION. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE UNIT WAS TESTED ON AN IN HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERRORS 23087 AND 25930 ON DEGREES OF FREEDOM (DOF) 5 AND 9. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) AND PASSED DIRECTION TESTS, LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, SINE CYCLE, BRAKE RELEASE TEST, BRAKE HOLD TEST, ADVANCED BRAKE TEST, CARRIAGE STRENGTH TEST, AND CARRIAGE SWITCHES TEST. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION - ISOLATED SURGICAL PROCEDURE, THE SYSTEM HAD ERROR 32087 AND IT WOULD NOT RECOVER. THE CUSTOMER POWER CYCLED THE SYSTEM AND WAS ABLE TO CONTINUE. THE SITE WAS ONLY USING 3 UNIVERSAL SURGICAL MANIPULATOR (USMS) FOR THE CASE, BUT WANTED TO POWER CYCLE INSTEAD OF BRINGING USM 4 AROUND TO USE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870857 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

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