BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20290014 · Received September 24, 2024

    Report

    Report Number
    2955842-2024-19680
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASSISTED THE CUSTOMER WITH REMOVING THE INSTRUMENT. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, AN INSTRUMENT WAS STUCK ON THE UNIVERSAL SURGICAL MANIPULATOR 1 (USM1). THE CUSTOMER UNDOCKED THE SYSTEM AND CONVERTING TO OPEN. THE CUSTOMER CONVERTED PRIOR TO CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE TSE WALKED THE CUSTOMER THROUGH MANUALLY REMOVING THE INSTRUMENT. THE CUSTOMER PROCEEDED WITH TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290078 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-36 N/A 00886874110720

    Patients

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