BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22879633 · Received August 22, 2025

    Report

    Report Number
    2955842-2025-34991
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 28, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE GREEN SUREFORM 45 RELOAD TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE STAPLER LOGS WAS PERFORMED FOR THIS PROCEDURE. THE SUREFORM 45 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM TEN TIMES AND FIRED TEN SUREFORM 45 RELOADS. ON EACH INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRINGS WERE BOTH COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. NO STAPLING ISSUES OR ERRORS WERE OBSERVED IN THE LOGS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE STAPLE LINE ON THE BRONCHUS OPENED ON POST-OPERATIVE DAY # 1. THE PROCEDURE WAS COMPLETED USING A SUREFORM 45 STAPLER INSTRUMENT WITH A GREEN SUREFORM 45 RELOAD. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE OF THE STAPLE LINE DEFECT, IF ANY ISSUES WERE OBSERVED BY THE CUSTOMER WHILE USING THE SUREFORM 45 STAPLER INSTRUMENT, AND WHAT MEDICAL INTERVENTION WAS PERFORMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2456489 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G-01 UNKNOWN

    Patients

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