BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 22392079 · Received July 3, 2025

    Report

    Report Number
    2955842-2025-28790
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    April 14, 2025
    Report Date
    November 3, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113834
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: STAPLES FELL OUT BEFORE SURGEON COULD FIRE. A NEW STAPLE LOAD HELPED WITH COMPLETING THE CASE.

    Additional Manufacturer Narrative · 0

    CORRECTION FOR USER FACILITY REPORT (B)(4) IN FIELD H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE STAPLES FELL OUT OF THE BEFORE THE SURGEON COULD FIRE. A NEW RELOAD WAS LOADED. NO FRAGMENT FELL INTO THE PATIENT. THE USER COMPLETED THE PROCEDURE AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530083 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-10 K10250102 10886874113834

    Patients

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