BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17917314 · Received October 11, 2023

    Report

    Report Number
    2955842-2023-19118
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 18, 2023
    Report Date
    September 18, 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
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE AND REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. ISI DID RECEIVE THE USM TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM VIA SYSTEM LOGS AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL TRIGGING 1126. THE ROLLING LOOP WAS FOUND TO BE DAMAGED. THE ROLLING LOOP WAS SWAPPED WITH A NEW ONE AND THE ERROR NO LONGER OCCURRED. THE ORIGINAL ROLLING LOOP WAS RECONNECTED, AND THE ERRORS RETURNED. THE ROLLING LOOP WILL BE REPLACED AS A FIX TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS GETTING AN ERROR WHERE THE STAPLER GOES INTO A FAULT MODE. CALLER STATED THEY RESTARTED THE SYSTEM AND THE ERROR REOCCURRED ON ARM 1. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND SAW A 307/319 ERROR POINTING TO UNIVERSAL SURGICAL MANIPULATOR (USM) AXES CONTROLLER CARRIAGE (ACC)/AXES CONTROLLER SPAR (ACS) BOARD. THE TSE WALKED CALLER THROUGH 2 HARD POWER CYCLES AND THE ERROR RETURNED WHEN THE SYSTEM POWERED ON. SURGEON DISABLED ARM 1 AND CONTINUE THE CASE WITH ARMS 2-3-4. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505277 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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