BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSEAL¿ TRINITY

    MDR report key: 14686574 · Received June 14, 2022

    Report

    Report Number
    3010377594-2022-00014
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    May 13, 2022
    Report Date
    August 11, 2022
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GEI
    UDI-DI
    00850346007047
    PMA / PMN Number
    K202114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE. 4 REPORTS ARE BEING SUBMITTED UNDER : 3010377594-2022-00013, 3010377594-2022-00015, 3010377594-2022-00016.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN ASSESSED AS A SERIOUS INJURY AND NOT AS A DEVICE MALFUNCTION. PLEASE REFER TO CORRECTIONS IN THIS DOCUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BETWEEN MAY 13 AND MAY 16TH A PHYSICIAN HAD 2 CASES OF 1 BAD SEALING AND 1 CASE WERE THE DEVICE STOPPED WOKING IN THE MIDDLE OF THE PROCEDURE. ANOTHER DEVICE HAD TO BE USED TO STOP THE BLEEDING. NO HARM REPORTED . 4 DEVICES WERE USED TOTAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878703 COOLSEAL¿ TRINITY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOLDER SURGICAL CSL-TR105-37 22020008 00850346007047

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other COOL SEAL TRINITY