BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19229751 · Received May 2, 2024

    Report

    Report Number
    2955842-2024-13924
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 4, 2024
    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
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) GENERATOR ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. THE UNIT WAS ANALYZED, AND THE REPORTED FAILURE WAS NOT CONFIRMED AND NOT REPLICATED. AN OBSERVATION THAT WAS NOT RELATED TO THE REPORTED COMPLAINT WAS THAT THE FRONT FRAME WAS CRACKED.

    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. FSE REPLACED THE ELECTROSURGICAL UNIT (ESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE.

    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, THE MONOPOLAR ENERGY WAS NOT WORKING. THE CUSTOMER USED AN EXTERNAL GENERATOR TO RESOLVE THE ISSUE. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845769 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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