BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIEGO CONSOLE SINUS SHAVER HANDPIECE

    MDR report key: 561100 · Received January 5, 2004

    Report

    Report Number
    561100
    Event Type
    Other
    Date Received
    January 5, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 5, 2004
    Manufacturer
    GYRUS ENT, LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THE DIEGO CONSOLE HANDPIECE TO THE GYRUS-ENT EARS NOSE THROATSINUS SHAVER BECOMES UNCOMFORTABLY HOT (105 DEGREES F) DURING USE. SEVERAL HANDPIECES WERE USED AND ALL WERE FOUND TO REACH UNCOMFORTABLY HOT TEMPERATURES. NO INJURIES TO PATIENT OR STAFF OCCURRED. EXTENSIVE TESTING WAS DONE WITH THIS DEVICE, SPECIFICALLY GYRUS-ENT (800-262-3540; WWW.GYRUS-ENT.COM), MODEL 70338000. THE HANDPIECES WERE RETURNED TO THE MANUFACTURER AND THE REPLACEMENTS HAD THE SAME HEAT PROBLEM WHEN TESTED. A COMPLAINT ABOUT THE DEVICE HAS BEEN FILED WITH THE MANUFACTURER; FACILITY IS REQUESTING THE MANUFACTURER PERFORM A QUALITY ANALYSIS ON THE HANDPIECE. FACILITY'S GYRUS-ENT REP AND CLINICAL ENGINEER, FILED THE DEVICE COMPLAINT WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIEGO CONSOLE SINUS SHAVER HANDPIECE SINUS SHAVER HRX GYRUS ENT, LLC 70338000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *