BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 17074232 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15980
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE DOUBLE CAMERA CONTROLLER (DOCO) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DOCO INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE DOCO WAS INSTALLED INTO A TEST SYSTEM WHICH WAS LAUNCHED IN MAINTENANCE MODE. THE SYSTEM THEN POWERED ON IN NORMAL MODE WHERE IT WAS CONFIRMED THAT THE WHITE BALANCE CALIBRATION STEP COULD NOT BE PASSED AND THE IMAGE THROUGH THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC) WAS RED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS FAILING THE WHITE CALIBRATION TEST. THE TECHNICAL SUPPORT ENGINEER (TSE) CHECK THE SYSTEM LOGS AND ASKED THE CUSTOMER TO REMOVE THE DRAPE AND CLEAN THE CAMERA HEAD AND THEN CHECK VISION WITH ONLY CAMERA HEAD. THE CUSTOMER CONFIRMED AFTER REMOVING THE DRAPE AND CLEANING THE CAMERA HEAD THAT THE WHITE BALANCE TEST STILL FAILED. THE TSE ASKED HIM TO HARD POWER CYCLE THE SYSTEM AND REBOOT THE ILLUMINATOR AND DOUBLE CAMERA CONTROLLER (DOCO). THE TSE REQUESTED THE CUSTOMER RESET THE CAMERA CABLE AS WELL. THE CUSTOMER CONFIRMED AFTER PERFORMING THIS ACTIVITY, THAT THE ISSUE WAS STILL THERE. THE TSE ASKED THE CUSTOMER TO USE A THIRD PARTY LIGHT SOURCE TO ENSURE THAT THE ISSUE WAS NOT RELATED TO THE ILLUMINATOR, BUT THERE WAS NO OTHER COMPATIBLE LIGHT SOURCE AVAILABLE TO CHECK THE ISSUE AT THE TIME. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020685 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A

    Patients

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