BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYRUS SINUS THRUCUT

    MDR report key: 1935299 · Received November 29, 2010

    Report

    Report Number
    1935299
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GYRUS ACMI
    Product Code
    LRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THRUCUT TIP BROKE OFF WHILE DR. WAS USING GYRUS SINUS THRUCUT FOR ENDONASAL RESECTION OF A TUMOR. THE DR. WAS ABLE TO RETRIEVE THE TIP WITHOUT INCIDENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYRUS SINUS THRUCUT INSTRUMENT, ENT LRC GYRUS ACMI * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR