BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 22663672 · Received July 30, 2025

    Report

    Report Number
    2955842-2025-32206
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 9, 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
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. INSUFFICIENT INFORMATION IS AVAILABLE FOR PROCEDURE VERIFICATION; THEREFORE, NO DA VINCI SYSTEM OR INSTRUMENT LOGS ARE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE PATIENT EXPERIENCED A BILE LEAK, SPECULATED TO HAVE BEEN CAUSED BY USING AN UNSPECIFIED SUREFORM STAPLER INSTRUMENT AND STAPLER RELOAD. THE EXACT CAUSE OF THE INCIDENT, AS WELL AS WHETHER THE PATIENT REQUIRED FURTHER MEDICAL OR SURGICAL INTERVENTION, REMAINS UNCLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444533 SUREFORM STAPLER 60 RELOAD GDW INTUITIVE SURGICAL, INC N/A N/A

    Patients

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