BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20818026 · Received December 2, 2024

    Report

    Report Number
    2955842-2024-22507
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPLETED FAILURE ANALYSIS INVESTIGATIONS. FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE A BROKEN GRIP AT THE GRIP BASE. PIECES MEASURING APPROXIMATELY 5.00MM X 12.00MM AND 4.15MM X 4.73MM WERE FOUND TO BE BROKEN OFF. THE BROKEN PIECES WERE RETURNED WITH THE INSTRUMENT. FURTHER INSPECTION OF THE RETURNED INSTRUMENT FOUND NO ADDITIONAL DAMAGE OR ABNORMALITIES.

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT GRIPPER BROKE OFF INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97821 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12230615 0254 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.