BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 20525562 · Received October 24, 2024

    Report

    Report Number
    2955842-2024-20895
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 30, 2024
    Report Date
    September 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOUBLE CAMERA CONTROLLER (DOCO) WAS INSTALLED ON THE TEST SYSTEM AND PASSED SINE CYCLE, POWER CYCLES AND IDLE TESTING WITHOUT ISSUE. THE SINE CYCLE WAS PERFORMED FOR TEN MINUTES, TWENTY POWER CYCLES AND IDLE TESTING WAS FOR THREE HOURS. THE ERROR 48232 ISSUE WAS CONFIRMED BUT NOT REPLICATED.

    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. THE FSE CONFIRMED THE REPEATED 48232 ERRORS AND REPLACED REPLACED THE DOUBLE CAMERA CONTROLLER (DOCO ) TO RESOLVE THE ISSUE. HOWEVER, AFTER THE REPLACEMENT AN ERROR 48230 APPEARED WITH A "LEFT VIDEO LOST" MESSAGE ON THE VISION SIDE CART (VSC) MONITOR. FSE REPLACED THE CAMERA HEAD TO RESOLVE THE FAULT. THE FSE REPLACED THE CAMERA CABLE PROACTIVELY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE CAMERA CABLE INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DOCO INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONALLY, INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE SITE TO RETURN THE CAMERA HEAD INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING (POST-ANESTHESIA) A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, A REPEATED RECOVERABLE FAULT 48232 OCCURRED ON THE LEFT DOBLE CAMERA CONTROLLER (DOCO). THE CUSTOMER PERFORMED A POWER CYCLE OF SYSTEM WITH NO CHANGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM A HARD POWER CYCLE OF THE VISION SIDE CART (VSC); HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, BUT THERE WERE NO ISSUES NOTED DURING SET UP OF THE SYSTEM. THE ISSUE WAS IDENTIFIED AFTER PORTS PLACEMENT. NO POST PROCEDURAL COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565037 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-16 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.