BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 25045005 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23367
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE SUSTAINED A FOOT INJURY MANEUVERING THE PATIENT SIDE CART (PSC). THE NURSE WAS POSITIONED ADJACENT TO THE CART AND HELD THE HANDLEBAR TO PUSH IT FORWARD. DURING THIS ACTION, THE NURSE'S FOOT BECAME TRAPPED UNDER ONE OF THE CART¿S WHEELS, RESULTING IN AN INJURY. THE INJURY DID NOT RESULT IN ANY FRACTURES, BUT THE NURSE REQUIRED UNSPECIFIED MEDICAL INTERVENTION AND TWO WEEKS OF RECOVERY. THE NURSE¿S CURRENT CONDITION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418925 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-40 N/A 00886874114605

    Patients

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