BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21528003 · Received March 5, 2025

    Report

    Report Number
    2955842-2025-03165
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    December 11, 2024
    Report Date
    February 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K140553
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    ON 05-FEB-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT WITH MDR REPORT #MW5165223 STATING: "DURING THE ROBOTIC SURGICAL PROCEDURE, THE SURGEON FOUND A SMALL BLACK CYLINDER LOOKING OBJECT IN THE PATIENT. IT WAS IMMEDIATELY TAKEN OUT OF THE THORACIC CAVITY. IT WAS INSPECTED UPON REMOVAL, AND IT APPEARED TO BE A BLACK THIN PLASTIC OBJECT. I SCRUBBED IN AND TOOK A LOOK AT THE OBJECT. IT APPEARED TO BE A PIECE OF THE DA VINCI STAPLER SHEATH. I INSPECTED BOTH ROBOTIC STAPLERS THAT WE HAD ON OUR STERILE FIELD, ALL OF THOSE STAPLERS WERE INTACT WITH NO MISSING PARTS OF THE STAPLER SHEATH. THE PIECE THAT WAS FOUND IN THE BODY WAS HELD UP TO THE LIGHT AND YOU COULD SEE THAT THERE WAS WRITING ON THE PIECE THAT SAID DA VINCI ON IT. SINCE ALL OF THE STAPLERS THAT WERE ON MY STERILE FIELD WERE INTACT, THE ONLY EXPLANATION THAT I CAN THINK OF IS THAT THIS PIECE WAS IN ONE OF THE 12 MM METAL DA VINCI TROCAR AND THAT THIS BLACK PLASTIC PIECE WAS FROM A PREVIOUS CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276077 ENDOWRIST STAPLER SHEATH NAY INTUITIVE SURGICAL, INC 410370-04 N/A

    Patients

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