BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL¿

    MDR report key: 21890668 · Received April 23, 2025

    Report

    Report Number
    21890668
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    February 4, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COOLSEAL DEVICE FAILED TO ACTIVATE. NO IDENTIFIED HARM PER THE OP [OPERATIVE PROCEDURE] NOTE. NO COMPLICATIONS LISTED. REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257916 COOLSEAL¿ ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI BOLDER SURGICAL, LLC 75GC3826

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Male