BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 20993686 · Received December 20, 2024

    Report

    Report Number
    2955842-2024-23526
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    November 27, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    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 EVENT. THE FSE WAS NOT ABLE TO REPRODUCE THE ISSUE WITH THE INSUFFLATOR. THE FSE PERFORMED A SYSTEM TEST DRIVE WITH INSUFFLATION AND NO TROUBLE WAS FOUND. HOWEVER, THE FSE CONFIRMED THAT THE SEAL THAT WAS CONNECTED THE AIR TANK TO THE HOSE LEADING INTO THE MANTLE ON THE VISION SIDE CART (VSC) WAS BROKEN. THE SURGICAL STAFF FIXED IT BY REPLACING WITH A GREEN PLASTIC SEAL, WHICH SEEMED TO WORK WELL. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. 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

    A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE) WHO CONFIRMED THE IMAGE LOOKS LIKE A WASHER SEAL THAT IS USED TO AID IN THE CONNECTION BETWEEN THE YOKE CONNECTOR AND THE CO2 TANK. THE WASHER SEAL IS NOT AN INTUITIVE PRODUCT. THE PROBABLE ROOT CAUSE OF THE LOSS OF INSUFFLATION IS ATTRIBUTED TO AN ISSUE WITH THE WASHER SEAL WHICH IS NOT AN INTUITIVE PRODUCT. THE CAUSE OF THE LOSS OF SYSTEM POWER COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SYSTEM CUT OUT AND COMPLETELY LOST INSUFFLATION. THERE WAS A 'POP' NOISE LIKE THE INSUFFLATOR TUBING WAS DISCONNECTED, AND THEN THE WHOLE SYSTEM POWERED OFF WITHOUT THE 10 SECONDS COUNTDOWN INCLUDING INSUFFLATION. THE OPERATING ROOM DID NOT LOSE ALTERNATING CURRENT (AC) POWER AT THE TIME OF THE EVENT. THE CALLER REPORTED THAT THEY WERE LOW ON TANK GAS AND THEY HAD REPLACED THE TUBE SET AS WELL AS THE GAS CYLINDER(S). PRIOR TO CALLING, THE SITE HAD POWERED THE SYSTEM BACK ON AND ALL ARMS BECAME RED. THE TSE OBSERVED ERROR 31004 IN THE LOGS. THE CALLER THEN PERFORMED ONE ADDITIONAL POWER CYCLE, AND THE SYSTEM CAME BACK ON WITH THE "DA VINCI IS READY" ANNOUNCED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER WAS PRESENT DURING THE PROCEDURE. DURING THE PROCEDURE, MORE INSUFFLATION WAS NEEDED, BUT THERE WAS A SUDDEN LOSS OF INSUFFLATION. THE SCREEN WENT BLANK, AND EVERYTHING SHUT OFF AS IF THERE WAS NO POWER. TROUBLESHOOTING WAS PERFORMED BY CHANGING THE TANK AND THE TUBE SET, BUT THE ISSUE WAS NOT RESOLVED, RESULTING IN A NON-RECOVERABLE FAULT. THE SYSTEM WAS RESTARTED, AND THE PROCEDURE WAS COMPLETED USING THE SAME INSUFFLATOR. AFTER THE PROCEDURE, FURTHER EXAMINATION REVEALED THAT THE SEAL USED DURING THE PROCEDURE HAD LIKELY POPPED. THERE WAS NO INJURY TO THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY USING THE SAME DA VINCI 5 TOWER. ISI ALSO FOLLOWED UP WITH THE ISI FIELD SERVICE ENGINEER (FSE) AND OBTAINED ADDITIONAL DETAILS: DURING THE FSE¿S VISIT, THE FSE FOUND THE SEAL WAS BROKEN AND THE CUSTOMER WAS USING A GREEN PLASTIC SEAL INSTEAD, WHICH SEEMED TO WORK WELL. THE FSE TESTED THE INSUFFLATOR AND DID NOT FIND ANY ISSUES. THE ISSUE WAS RELATED TO THE SEAL THAT CONNECTS THE AIR TANK TO THE HOSE LEADING INTO THE MANTLE ON THE VISION SIDE CART (VSC).

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375748 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A

    Patients

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