BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES

    MDR report key: 3865394 · Received May 16, 2014

    Report

    Report Number
    3865394
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ATRICURE, INC
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WIRE HOLDING THE ARTICULATING PARTS TOGETHER ON HERCULES RETRACTOR BROKE. THIS RESULTED IN PIECES FALLING AROUND OPEN CHECK WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293605 HERCULES RETRACTOR GAD ATRICURE, INC 401-152 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR