BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP

    MDR report key: 21298165 · Received January 31, 2025

    Report

    Report Number
    MW5165604
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 26, 2025
    Report Date
    January 30, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP/DISPOSABLE DID NOT WORK PROPERLY; REF-A001144; LOT-146984. THE JAWS OF THE CLAMP WOULD NOT APPROXIMATE. NO HARM TO THE PATIENT; A SECOND CLAMP WAS OPENED AND USED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246139 ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING OCL ATRICURE, INC. A001144 146984

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male