BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL TRINITY

    MDR report key: 11756197 · Received April 30, 2021

    Report

    Report Number
    3010377594-2021-00003
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GEI
    UDI-DI
    00850346007047
    PMA / PMN Number
    K202114
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 20120013 WAS REVIEWED. NO ANOMALIES WERE NOTED ON THE LOT RELEASE PAPERWORK. THE INCIDENT UNIT WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE MET ALL SPECIFICATIONS AND PERFORMANCE REQUIREMENTS. NO DEVICE RELATED CAUSE OF THE REPORTED INCIDENT HAS BEEN IDENTIFIED. THE REPORTED INCIDENT MAY HAVE BEEN RELATED TO THE DISEASE STATE OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAP ILEOCOLIC RESECTION, THE SEALER, USED EXTRACORPOREALLY, WAS NOT SEALING WELL. THE SURGEON REPORTED THAT AFTER A DOUBLE SEAL, THE BLEEDING PERSISTED. THE MESENTERY WAS CUT AND TIED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS AND THE PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654401 COOLSEAL TRINITY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOLDER SURGICAL CSL-TR105-37 20120013 00850346007047

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR