BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL¿ REVEAL

    MDR report key: 18758049 · Received February 22, 2024

    Report

    Report Number
    18758049
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    November 2, 2023
    Report Date
    November 8, 2023
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEFECT, HINGE BROKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576173 COOLSEAL¿ REVEAL ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI JUSTRIGHT SURGICAL, LLC CSL-RV105-10 23060001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown