BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18097392 · Received November 8, 2023

    Report

    Report Number
    2955842-2023-20078
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 ISI FSE REPLACED THE E-100 GENERATOR TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM A FAILURE ANALYSIS. THE GENERATOR WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATIONS, AND THE REPORTED FAILURE WAS REPLICATED. THIS UNIT WAS INSTALLED ONTO THE TEST SYSTEM AND FAILED TO TEST. THE POWER LED TURNED RED, AND THE BIPOLAR LED DID NOT TURN ON AND COULD NOT CUT/SEAL. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS.

    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 ISI FSE REPLACED THE E-100 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A CALLER REPORTED THAT THE E-100 WAS NOT WORKING, THE CUSTOMER CALLED TECHNICAL SUPPORT AFTER THE ISSUE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO REBOOT THE E-100 AND ALL SYSTEMS, BUT THE ISSUE REOCCURRED. THE ISI TSE ASKED TO VERIFY ALL CONNECTIONS. THERE WAS NO DELAY AND NO ISSUE INVOLVED TO PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE E-100 DIDN'T¿ WORK AT THE BEGINNING OF THE PROCEDURE, AND THE CUSTOMER DECIDED TO USE THE ERBE VIO. THE ISSUE OCCURRED DURING THE PROCEDURE, WITH NO HARM TO THE PATIENT AND NO FRAGMENT FALLING INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT. IN ADDITION, THE INCIDENT DID NOT RESULT IN A PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537282 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

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