BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 16971379 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-14009
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    August 18, 2020
    Report Date
    August 19, 2020
    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
    MI, 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 ILLUMINATOR WAS HAVING INTERMITTENT VISION ISSUES DUE TO NOT BEING ABLE TO WHITE BALANCE. FSE INSTALLED NEW ILLUMINATOR AND POWER CYCLED 3 TIMES AND ALL 3 TIMES FSE WAS ABLE TO WHITE BALANCE AND HAVE CLEAR VISION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT CONFIRM THE REPORTED FAILURE. ACCORDING THE TRACK WISE CUSTOMER REPORT IMAGE DIM. THE ISSUE WAS INTERMITTENT AND LAMP FAILED TO LIGHT. PERFORMED VISUAL INSPECTION I FOUND THE FRONT VENTILATION WINDOW WAS DIRTY AND THE FRONT PLASTIC COVER HAS SCRATCHES. IN-HOUSE FA: INSTALLED THE UNIT INTO THE PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND POWERED UP NO ERROR. PERFORMED 10X SYSTEM POWER CYCLES TESTED WELL. CHECK THE VIDEO IMAGE NORMAL. HOWEVER, BECAUSE THIS UNIT WAS FAILED INTERMITTENT PROBLEM IT WAS RECOMMENDED RETURN TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) RECERTIFICATION THIS UNIT FOR PRECAUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER NOTED A WHITE BALANCE FAILURE WITH MOST OF THEIR ENDOSCOPES. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED UP WITH THE SITE AND COMMUNICATED A POSSIBLE ILLUMINATOR REPLACEMENT TO FIX ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781592 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-06 N/A

    Patients

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