BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17183100 · Received June 22, 2023

    Report

    Report Number
    2955842-2023-16516
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    May 26, 2023
    Report Date
    May 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-RECOVERABLE FAULT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONSULTED ISI TECHNICAL SUPPORT AND CONCLUDED THAT THE UNIVERSAL POWER DISTRIBUTOR (UPD) WAS THE MOST LIKELY CAUSE OF THE ERROR. THE FSE REPLACED THE CARD CAGE, WHICH CONTAINED THE UPD. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVED THE CARD CAGE INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE CARD CAGE WAS ANALYZED AND THE REPORTED FAILURE WAS REPLICATED/CONFIRMED. THE CARD CAGE WAS INSTALLED AND TESTED ON THE TEST SYSTEM. THE SYSTEM STARTED UP AND FAILED WITH THE ERROR. THE UPD OF THE CARD CAGE WAS TO BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PEDIATRIC PYELOPLASTY PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT. THE CUSTOMER STATED THEY REBOOTED THE SYSTEM ONCE BEFORE CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT, BUT THE NON-RECOVERABLE ERROR RETURNED. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TRYING A HARD REBOOT ON THE SYSTEM. THE TSE WALKED THE CUSTOMER THROUGH THREE HARD REBOOTS ON THE SYSTEM, BUT THE FAULT RETURNED UPON POWER UP. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER WAS UNABLE TO RESOLVE THE ISSUE VIA TROUBLESHOOTING AND CHOSE TO CONVERT TO OPEN SURGERY. THE SURGEON EXTENDED ONE OF THE PORT INCISIONS FOR THE OPEN SURGERY. THE PATIENT TOLERATED THE CONVERSION WELL AND THERE WAS NO HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028761 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male DA VINCI INSTRUMENTS AND ACCESSORIES