BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 19210561 · Received April 29, 2024

    Report

    Report Number
    2955842-2024-13853
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 3, 2024
    Report Date
    April 3, 2024
    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
    NJ, 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 EVENT. FSE CONFIRMED ERROR 23069 ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND REPLACED IT TO RESOLVE THE ISSUE. SYSTEM HAS BEEN TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ANALYSIS IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE USM IS EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND COMPLETED THE PRODUCT EVALUATION. THE USM 1 WAS ANALYZED, AND THE ERROR 23069 WAS CONFIRMED AND REPLICATED. THE SYSTEM LOG SHOWS MULTIPLE 23069 ERRORS OCCURRING ON USM 1 POINTING TOWARD THE PITCH AXIS. THERE ARE ALSO ERRORS POINTING TOWARD PITCH. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 23069 ERROR. THE UNIT ALSO FAILED THE PITCH CHARACTERIZATION TEST. DURING INVESTIGATION, NO FLUID INTRUSION OR DAMAGE WAS SEEN AROUND THE PITCH OR FLEX CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERROR 23069. SITE DISABLED UNIVERSAL SURGICAL MANIPULATOR (USM) 1 AND WAS USING 3 USMS TO COMPLETE THE PROCEDURE. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED ERROR 23069 IN THE LIVE LOGS POINTING TO USM1 AXIS 2. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    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
    170820 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-37 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES