BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 21526753 · Received March 5, 2025

    Report

    Report Number
    2955842-2025-02340
    Event Type
    Injury
    Date Received
    March 5, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PULMONARY LOBECTOMY, THE BRONCHUS WAS STAPLED WITH A GREEN SUREFORM 45 RELOAD THAT WAS INSTALLED ON A SUREFORM 45 STAPLER INSTRUMENT. A SUBSEQUENT LEAK TEST SHOWED A LEAK FROM THE BRONCHUS. THE LEAK WAS FROM THE MUCOUS MEMBRANE WHERE A STAPLE WAS DEFORMED. IT IS UNKNOWN WHAT MEDICAL/SURGICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276003 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G N/A

    Patients

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