BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 17015617 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14742
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    December 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE UNIVERSAL POWER DISTRIBUTOR (UPD) AND UNIVERSAL POWER MODULE (UPM) BOARDS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPRODUCED THE CUSTOMER REPORTED ISSUE. THE UPD AND UPM WERE INSTALLED AND TESTED ON A SYSTEM. THE SYSTEM WAS UNABLE TO POWER ON. THE PATIENT SIDE CART (PSC) POWER BUTTON OUTER RING WAS FLASHING BLUE LIGHT, WHILE THE CENTER OF THE BUTTON REMAINED AMBER. ALL ARMS WERE OFF. THE UPD HAD A POWER ISSUE. AFTER REMOVING THE UPD, THE UPM REMAINED IN THE TEST SYSTEM FOR THE NEXT 24 HOURS AND IT PERFORMED WITHOUT ANY ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) WOULD NOT POWER ON. THE TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THE SITE RESEAT THE BLUE FIBER CABLES. THE SITE HAD DONE SO ALREADY AS WELL AS USED A NEW BLUE FIBER CABLE TO CONNECT TO THE PSC. THE TSE HAD THE SITE MAKE SURE THE MAIN BREAKER AT THE PSC WAS ON, THE EMERGENCY POWER OFF (EPO) WAS NOT TRIGGERED, AND THAT THE PSC WAS CONNECTED TO A PROPER AC SOURCE. THE TSE HAD THE SITE POWER DOWN THE SYSTEM, RESEAT ALL CABLES, AND BRING THE SYSTEM BACK ON; HOWEVER, THIS DID NOT HELP. THE SITE COULD NOT HEAR THE FANS FROM THE PSC. THE TSE HAD THE SITE MOVE THE UNIVERSAL SURGICAL MANIPULATOR (USM), BUT THERE WAS NO IMPROVEMENT. THE PSC LIGHT EMITTING DIODES (LEDS) WERE GREEN SHOWING THE BATTERY WAS FULLY LOADED. THE SITE PERFORMED AT LEAST 4 POWER CYCLES WITHOUT ANY SUCCESS. THE TSE HAD THE SITE CHECK THE SURGEON SIDE CONSOLE (SSC) BLUE FIBER CABLE AND CONNECT IT TO THE PSC WITHOUT SUCCESS. THE PSC COULD NOT START IN STAND ALONE MODE. THE SITE DID NOT WANT TO CONTINUE WITH TROUBLESHOOTING WITH ISI TECHNICAL SUPPORT. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO SURGERY. THE PATIENT SIDE CART (PSC) HAD POWER AT THE TIME THE PORTS WERE PLACED ON THE PATIENT. THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ERRORS SHOWN ON THE MONITOR AS THE PSC WAS NOT POWERED ON. THE CUSTOMER TRIED DIFFERENT AC POWER OUTLETS, CHANGED THE BLUE FIBER CABLE, AND CALLED DVSTAT TO TROUBLESHOOT. THE FSE REPAIRED THE SYSTEM. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916402 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-38 N/A 00886874115404

    Patients

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