BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22541250 · Received July 18, 2025

    Report

    Report Number
    2955842-2025-30400
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 19, 2025
    Report Date
    June 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS RESOLVED WITH PHONE SUPPORT. THE SURGEON USED INDOCYANINE GREEN (ICG) DYE TEST TO ENSURE THE TISSUE WAS NOT NECROTIC. THE PROCEDURE WAS COMPLETED ROBOTICALLY. NO FIELD SERVICE SITE VISIT WAS REQUIRED. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE ANY DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS (FA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE STAPLE LINE OF A GREEN SUREFROM 60 RELOAD REQUIRED INTERVENTION. WHILE FIRING A GREEN SUREFORM 60 RELOAD ON SIGMOID TISSUE, THE FIRING SEQUENCE WAS COMPLETED WITHOUT ANY COMPLICATIONS OR ERRORS. THE STAPLE LINE LOOKED INTACT AND COMPLETE. AN EEA METAL SIZER WAS PLACED, AND SLIGHT PRESSURE WAS APPLIED AGAINST THE GREEN RELOAD STAPLE LINE WITH THE EEA SIZER WHEN THE STAPLE LINE CAME APART, CREATING A HOLE. THE STAPLE LINE WAS OVER-SUTURED TO REPAIR THE DEFECT. THE SURGEON USED THE INDOCYANINE GREEN (ICG) DYE TEST TO ENSURE THE TISSUE WAS NOT NECROTIC. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT IS REPORTED TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400119 SUREFORM STAPLER 60 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48360G N/A

    Patients

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