BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLSEAL¿ TRINITY

    MDR report key: 14687367 · Received June 14, 2022

    Report

    Report Number
    3010377594-2022-00019
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BOLDER SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K202114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WHILE USING A TRINITY DEVICE , THE SEALS WERE NOT ADEQUATED. AFTER REMOVING THE PATIENT´S UTERUS THE PHYSICIAN NOTICED BLEEDING FROM THE SEALS. THE PHYSICIAN USED A LIGASURE TO STOP THE BLEEDING AND COMPLETED THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426455 COOLSEAL¿ TRINITY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOLDER SURGICAL CSL-TR105-37

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R