BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971380 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14010
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    August 20, 2020
    Report Date
    August 20, 2020
    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
    OH, US
    Reporter Occupation
    NURSE
    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 COMPLAINT. THE FSE WENT ON SITE AND REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE REPORTED COMPLAINT OF ERROR 23002. THE ARM WAS TESTED ON IN-HOUSE SYSTEM, IT FAILED NORMAL MODE AS IT TRIGGERED 23008/23118 ERRORS. WHEN THE ARM WAS TESTED ON PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP), IT PASSED DIRECTION TEST, LISSAJOUS, BRAKE RELEASE, CARRIAGE STRENGTH, FRICTION SPEED VERY SLOW, CARRIAGE SENSORS CHECK, CARRIAGE FRICTION LOW AND HIGH AND ADVANCED BRAKE TEST BUT FAILED INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA), INSERTION SENSOR CHECK, SINE CYCLE (ERROR 23118), FRICTION SPEED LOW (FALSE ERROR) AND HIGH (FALSE ERROR) WEIGHTED TEST (FALSE ERRORS). THE ARM WAS THEN OPENED FOR INSPECTION, FLUID INTRUSION WERE SEEN ALONG TORNADO SWITCH ASSEMBLY, CANNULA ACSC AND INSERTION AXIS CVA CPA. INSERTION CVA DISC, CVA PCA, FFC'S (18115) AND 181142), ACSC AND TORANDO SWITCH ASSEMBLY WILL BE REPLACED AS A FIX TO THE REPORTED PROBLEM. PER VISUAL INSPECTION, BURNT MARKS WERE OBSERVED FROM CARRIAGE TOP PLATE. TOP PLATE WILL BE REPLACED. CARRIAGE FAN FAILED DURING FAN TEST. CARRIAGE FAN WILL BE REPLACED. INSERTION LED WAS DIMDURING TESTING. INSERTION LED PCA WILL BE REPLACE. PER INSPECTION, TORNADO SWITCH ASSEMBLY HAS FLUID INTRUSION. TORNADO SWITCH ASSY WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, A RECOVERABLE ERROR 23002 WAS DISPLAYED. THE SITE CALLED IN PRIOR TO DOCKING AND STATED THAT THEY WERE GETTING A RECOVERABLE ERROR ON ARM 4. THE CUSTOMER RESTARTED THE SYSTEM WITH NO CHANGE. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD A SITE PERFORM A HARD RESTART AND MOVE ARM 4 AROUND WITH BUT THE ISSUE PERSISTED. THEN, THE TSE HAD THE SITE DISABLE ARM 4, AND THE SITE PROCEEDED WITH THE CASE. THE SITE WAS COMPLETING THE PROCEDURE WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781593 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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