BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIRWAN

    MDR report key: 20639713 · Received November 8, 2024

    Report

    Report Number
    20639713
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 7, 2024
    Manufacturer
    KIRWAN SURGICAL PRODUCTS LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DISPOSABLE 25 GAUGE BIPOLAR PENCIL, STRAIGHT, KIRWAN SURGICAL PRODUCTS LLC (WET FIELD/DIATHERMY) FILAMENT PROTECTIVE SHEATH CAME OFF WHEN THE SURGEON REMOVED THE INSTRUMENT FROM THE RIGHT EYE. THE SHEATH STAYED IN THE EYE AND POKED A HOLE IN THE RETINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815126 KIRWAN ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI KIRWAN SURGICAL PRODUCTS LLC 14-5011 240115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention