BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 19564690 · Received June 19, 2024

    Report

    Report Number
    2955842-2024-15478
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS DISPLAYED REVERSED IMAGE. THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BY RESEATING THE ENDOSCOPE ON ARM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPE WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. THE ENDOSCOPE WOULD NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578147 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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