BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20030247 · Received August 22, 2024

    Report

    Report Number
    2955842-2024-18126
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 22, 2024
    Report Date
    July 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER CONDUCTED AN ONSITE VISIT AND WAS UNABLE TO REPRODUCE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE PATIENT RECEIVED A BURN NEXT TO THE PORT SITE WHEN REMOVING THE PORT. THE TISSUE AROUND THE PORT WAS EXCISED AND CLOSED IN A STANDARD FASHION. THE SITE WAS USING A BIPOLAR INSTRUMENT IN THAT UNIVERSAL SURGICAL MANIPULATOR (USM). THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986375 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES