BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 19562907 · Received June 18, 2024

    Report

    Report Number
    2955842-2024-15806
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110799
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ILLUMINATOR WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND WAS UNABLE TO POWER UP WITH AN ERROR.

    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 REPLACED ILLUMINATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE DEVICE FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THERE WAS A RECOVERABLE 45310 FAULT. THE INSTRUMENT HAD GRASPED THE TISSUE AND THE TSE SUGGESTED THAT THEY RELEASE THE TISSUE BY USING THE INSTRUMENT RELEASE KEY (IRK). THEY CONFIRMED TISSUE RELEASE BY USING THE IRK. THE TSE SUGGESTED THAT THEY REBOOT THE SYSTEM. IT WAS CONFIRMED ERROR 297 AFTER REBOOT. THE TSE REVIEWED LOGS AND TOLD THEM THAT THE ILLUMINATOR NEEDED TO BE REPLACED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CASE WAS CONVERTED TO OPEN SURGERY DUE TO LOSS OF VISION AS THE LIGHT SOURCE ON THE CAMERA WAS NOT FUNCTIONAL. THERE WAS A SYSTEM MALFUNCTION INTRA-OPERATIVELY AND TROUBLESHOOTING WAS PERFORMED WITH THE DA VINCI SURGERY TECHNICAL ASSISTANCE TEAM (DVSTAT). THE PATIENT WAS NOT HARMED BECAUSE OF THE MALFUNCTION. THE LOSS OF LIGHT SOURCE FROM THE CAMERA RESULTED IN A MALFUNCTION WHICH LED TO LOSS OF VISION DURING THE PROCEDURE. THE SYSTEM WAS INSPECTED PRIOR TO THE CASE AND THE PROCEDURE PROGRESSED FOR 20 MINUTES BEFORE THE MALFUNCTION. NO POST-OPERATIVE COMPLICATIONS OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779937 DAVINCI SI VISION SIDE SYSTEM, RECERTIFIED NAY INTUITIVE SURGICAL, INC 380690-03 N/A 00886874110799

    Patients

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