BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSEAL¿ REVEAL

    MDR report key: 19793111 · Received July 22, 2024

    Report

    Report Number
    3010377594-2024-00004
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    July 8, 2024
    Report Date
    September 9, 2024
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GEI
    UDI-DI
    00850346007092
    PMA / PMN Number
    K203640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    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. H3: 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. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND VISUAL INSPECTION WAS CONDUCTED, A TINY PIECE OF TISSUE WAS FOUND WITHIN THE KNIFE HOLE. KNIFE COULD BE ACTUATED AND RETRACTED WITHOUT ANY ADDITIONAL FORCE (THE KNIFE WAS NOT PROTRUDING NOR CREATING ANY SORT OF SHORT/OPEN CIRCUIT). FUNCTIONAL TESTING WAS CONDUCTED AND THE DISPOSABLE COULD SEAL AND CUT AS INTENDED, THE SPLAY MEASUREMENT WAS PERFORMED AND IT WAS INSIDE THE EXPECTED PARAMETERS. THE DEVICE MET THE MANUFACTURER´S SPECIFICATIONS THUS THE COMPLAINT COULD NOT BE CONFIRMED. THIS OBSERVATION WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A COOLSEAL REVEAL PROCEDURE ON (B)(6) 2024, THE SURGEON REPORTED THAT THEY COULD NOT SEAL SMALL VESSELS DURING A THYROIDECTOMY. SURGEON REPORTED THAT THERE WAS AN UNCONTROLLED BLEEDING FROM SMALL VESSELS WHICH WAS EASILY MANAGED BUT PROBLEMATIC, THEY HAD TO USE A HARMONIC TO CONTROL THE BLEEDING. PATIENT WAS DOING FINE. NO OTHER COMPLICATIONS WERE REPORTED. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249647 COOLSEAL¿ REVEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOLDER SURGICAL CSL-RV105-10 23G27RT 00850346007092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other