BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 17047258 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15563
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 29, 2021
    Report Date
    April 29, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 CUSTOMER CALLED IN STATING THAT THE LIGHT SOURCE WENT OUT. THE BIOMEDICAL WENT BACK IN ROOM WHEN THE CASE WAS COMPLETED TO VERIFY THE ISSUE. A NON-RECOVERABLE ERROR 297 APPEARED WHEN THE SYSTEM WAS TURNED ON. THE FSE WENT ON SITE TO TROUBLESHOOT AND FOUND ERROR WAS OCCURRING DUE TO ERROR 48238 COMING FROM THE ILLUMINATOR. THE FSE REPLACED THE ILLUMINATOR TO RESOLVE FAULTY CONDITION. THE SYSTEM STARTED WITHOUT ERROR AND THE ILLUMINATOR FUNCTIONED PROPERLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PART INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE REPORTED FAILURE LIGHT WENT OUT DURING THE CASE. THERE ARE ERRORS 48238 AND 297 IN THE LOGS MEANS COMMUNICATION ISSUE. THE ILLUMINATOR WAS INSTALLED INTO PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND IT FAILED TO POWER UP THE VISION SIDE CART (VSC) WITH ERRORS 48238 AND 297. ONE BAD FUSE WAS FOUND UPON VISUAL INSPECTION. NO LAMP INSIDE UNIT AND GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIOMEDICAL ENGINEER CALLED IN STATING THAT THE CUSTOMER INFORMED HIM THE LIGHT FOR THE ILLUMINATOR WENT OUT. HE WAS NOT IN THE ROOM AT THE TIME. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30306 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-03 N/A

    Patients

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