BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FO LARYNGOSCOPE HANDLE

    MDR report key: 2901513 · Received January 3, 2013

    Report

    Report Number
    1044475-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    TELEFLEX
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RETURNED FOR EVAL, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE HANDLE TO THE LARYNGOSCOPE WOULD BECOME TOO HOT TO HANDLE WHEN IT WAS ATTACHED TO THE METAL BLADE. THE DEFECT WAS DISCOVERED DURING TESTING AND ONLY WHEN THE BLADE WAS ENGAGED WITH THE HANDLE. NO REPORT OF USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2978 RUSCH GREENSPEC FO LARYNGOSCOPE HANDLE FIBEROPTIC LARYNGOSCOPE HANDLE EQN TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1