BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 24243324 · Received February 3, 2026

    Report

    Report Number
    2955842-2026-02824
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 8, 2026
    Report Date
    February 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B1, B5, D1, D2A, D4, H2, H6, H11. ADDITIONAL INFORMATION: FURTHER INFORMATION CLARIFIED THAT THE INSTRUMENT INVOLVED IN THE ARTERIAL INJURY WAS THE MONOPOLAR CURVED SCISSORS (MCS). ACCORDING TO THE MEDICAL ENGINEER, THE SURGEON WAS UNABLE TO ACCURATELY IDENTIFY THE LOCATION OF THE MCS, AS IT WAS POSITIONED DEEPER THAN THE SURGEON REALIZED. THE SPECIFIC TASK BEING PERFORMED AT THE TIME OF THE INJURY REMAINS UNKNOWN. THE EXTENT OF BLEEDING AND ESTIMATED BLOOD LOSS WERE NOT SPECIFIED, NOR IS IT KNOWN WHETHER A BLOOD TRANSFUSION WAS REQUIRED. HEMOSTASIS WAS ACHIEVED FOLLOWING CONVERSION TO OPEN SURGERY; HOWEVER, THE SPECIFIC METHOD OF RESOLUTION WAS NOT PROVIDED. THE PATIENT¿S POSTOPERATIVE STATUS AND WHETHER ANY COMPLICATIONS OCCURRED ALSO REMAIN UNKNOWN. ACCORDING TO THE SURGEON, THE DA VINCI SYSTEM, INSTRUMENTS, AND ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, BLEEDING OCCURRED WHEN AN UNSPECIFIED FORCEPS INSTRUMENT CONTACTED AN UNSPECIFIED ARTERY. DESPITE ATTEMPTS TO ACHIEVE HEMOSTASIS USING COMPRESSION WITH THE FORCEPS INSTRUMENT AND GAUZE, THE BLEEDING COULD NOT BE CONTROLLED, REQUIRING CONVERSION TO OPEN SURGERY. WHILE THE SYSTEM WAS UNDOCKED, THE ENDOSCOPE REMAINED IN USE FOR FIREFLY IMAGING. ACCORDING TO THE SURGEON, THE DA VINCI SYSTEM, INSTRUMENTS, AND ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE CAUSE OF THE INJURY AND DETAILS OF ITS REPAIR REMAIN UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552270 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K11250320 0185 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES