BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17067604 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15835
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    June 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    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 FSE NOTED THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV) WAS DEAD/BLACK. THE FSE REPLACED THE LEFT HRSV TO CORRECT THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HRSV WAS RETURNED TO ISI FOR FAILURE ANALYSIS (FA). FA INVESTIGATION DID NOT CONFIRM NOR REPLICATE THE CUSTOMER REPORTED PROBLEM. AFTER TESTING, NO PARTS OR COMPONENTS NEEDED TO REPLACED OR REPAIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE LEFT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. IT WAS NOTED THAT THE IMAGE WAS FINE ON THE VISION SIDE CART (VSC) TOUCHSCREEN MONITOR. THE SYSTEM WAS DOCKED TO THE PATIENT, AND THE SURGEON WAS STARTING THE SURGERY WHEN THEY NOTICED THE LEFT EYE WAS BLACK IN THE SSC. THE SURGEON HAD POWER-CYCLED THE SYSTEM WITH NO SUCCESS. THE SURGEON THEN UNDOCKED FROM THE PATIENT AND CONTACTED THE TSE FOR TROUBLESHOOTING. THE TSE HAD THE SURGEON CYCLE THE SYSTEM POWER AND SSC CIRCUIT BREAKER FOR OVER ONE (1) MINUTE, AND THE SYSTEM POWERED ON AND HOMED SUCCESSFULLY. THE TSE HAD THE SURGEON RESEAT THE SSC BLUE FIBER CABLE WHILE THE SYSTEM WAS POWERED OFF AND CHECK THE DIGITAL VIDEO INTERFACE (DVI) VIDEO OUTPUT CABLE ON THE BACK OF THE SSC, AND IT WAS CONFIRMED NO DVI CABLES WERE CONNECTED. IT WAS NOTED THAT THE LEFT EYE IN THE SSC WAS STILL BLACK, AND THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570201 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-11 N/A 00886874110744

    Patients

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