BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20509665 · Received October 22, 2024

    Report

    Report Number
    2955842-2024-20820
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    September 24, 2024
    Report Date
    September 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/04/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5160345 STATING THE FOLLOWING: "AN INTUITIVE DAVINCI PROGRASP FORCEP WAS BEING USED IN A ROBOTIC CASE AND THE PIN HOLDING ONE OF THE PULLIES ON THE DISTAL TIP OF THE GRASPING FORCEP FELL OUT INTO THE PATIENT. WHEN THIS PIN FELL OUT IT WAS NOT INITIALLY OBSERVED, BUT AS THE SURGEON CONTINUED TO TRY AND WORK, HE NOTED THAT THE DEVICE WAS NOT WORKING PROPERLY. THE PROGRASP FORCEP WAS PULLED OUT OF THE CANNULA PORT AND UPON FURTHER INVESTIGATION AS TO WHY IT WAS NO LONGER PERFORMING IS WHEN THE PIN WAS IDENTIFIED AS MISSING. THE SURGEON WENT BACK INTO THE BODY CAVITY TO SEARCH AND RETRIEVE THE MISSING PIN. THANKFULLY IT WAS FOUND."

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, A PATIENT SAFETY EVENT OCCURRED WHERE ONE OF THE PINS IN THE DISTAL TIP OF A PROGRASP FORCEPS INSTRUMENT FELL INSIDE THE PATIENT. THE FALLEN PIN WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789720 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 470093-11 UNK

    Patients

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