BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22049718 · Received May 20, 2025

    Report

    Report Number
    2955842-2025-21001
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    March 31, 2025
    Report Date
    April 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE COMPLAINT INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE COMPLAINT WILL BE REEVALUATED AT INVESTIGATION COMPLETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT STOPPED WORKING. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 24-APR-2025: THE SR. OPERATING ROOM (OR) PERSONNEL INFORMED THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT COULD NOT BE CONTROLLED. IT WAS CLARIFIED THAT THE INSTRUMENT COULD NOT MOVE OR STOPPED. THE INSTRUMENT WAS JAMMED AND COULD NOT BE OPENED OR CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142372 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K19240229 0229 00886874112298

    Patients

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