BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 17039811 · Received June 1, 2023

    Report

    Report Number
    2955842-2023-15449
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    September 9, 2021
    Report Date
    September 10, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ENDOSCOPE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE CAMERA INSTRUMENT WAS NOTED WITH DAMAGED STAGE ASSEMBLY, WORN OUT HOUSING COMPONENTS, AND A CUT IN THE LIGHT CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA-BILATERAL SURGICAL PROCEDURE, THE PICTURE WAS DISTORTED. THE CUSTOMER CHANGED OUT THE ENDOSCOPE WITH NO SUCCESS. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO AN OPEN SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THAT THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND CONFIRMED THAT THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017903 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-05 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES