BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 20921063 · Received December 12, 2024

    Report

    Report Number
    2955842-2024-23214
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 19, 2024
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE AIR FILTER AND POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE CORE POWER TRAY ASSEMBLY WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED THROUGH INTERNAL NOTES BUT NOT REPLICATED. IN LOGS, THIS FAILURE WAS NOTED INDICATING AN ALTERNATING CURRENT (AC) FAILURE CONFIRMING THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. HOWEVER, THERE ARE VISIBLE COSMETIC DEFECTS; BADLY OXIDIZED CASING AND BOARD, BENT MOUNTING STUD. PERFORM POWER SUPPLIES 12 V TEST CHECK ON BOTH POWER SUPPLY AND IT PASSED THE TEST. THIS CORE POWER TRAY ASSEMBLY WAS INSTALLED AND TESTED ON A SYSTEM WITH NO ISSUE ON STARTUP AND NO ERRORS OR FAILURES WERE TRIGGERED. THIS ASSEMBLY WENT THRU A 12 POWER CYCLES WITH NO ISSUE, IDLE IN NORMAL MODE FOR 3 HOURS WITH NO ISSUE AND NO ERROR TRIGGERED. CHECK ON VOLTAGE AND CURRENT, ALL PASSED WITH NORMAL RANGE. AS A RESULT OF THIS TEST, FAILURE ANALYSIS CONCLUDED THAT THERE IS NO TROUBLE FOUND WITH THIS UNIT. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE ELECTRICAL DEFECT OF THE CORE POWER TRAY ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE VISION SIDE CART (VSC) TURNED OFF SUDDENLY DURING THE PROCEDURE AND NO LED STATUS ON CORE REAR SIDE AND POWER BUTTON. TSE SUGGESTED HARD POWER CYCLE, VERIFY WALL SOCKET POWER, RESEAT THE POWER CORDS. THE CUSTOMER WAS UNABLE RESOLVE THE ISSUE. TSE INFORMED CUSTOMER SYSTEM WAS DOWN AND FSE WILL DO FURTHER TROUBLESHOOTING. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UP POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY AND IT WAS UNKNOWN IF PORTS WERE INCREASED OR ADDITIONAL PORTS WERE ADDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859244 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-09 N/A

    Patients

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