BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL TRINITY

    MDR report key: 17860048 · Received October 3, 2023

    Report

    Report Number
    17860048
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 19, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BOLDER SURGICAL, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STAFF REPORTED THE JAW OF THE COOLSEAL DEVICE BROKE DURING USE WHEN SURGEON USED TO CONTROL A BLEEDING VESSEL. DEVICE WAS SAFELY REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414688 COOLSEAL TRINITY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOLDER SURGICAL, LLC CSL-TR105-37 22L30RA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female