BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE, SMALL

    MDR report key: 2961228 · Received January 28, 2013

    Report

    Report Number
    1044475-2013-00016
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 15, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN THE BIOTECH INSTALLED 2 "AA" BATTERIES INTO THE GREEN SPEC HANDLE THE LIGHT CAME ON IMMEDIATELY AND WOULD NOT TURN OFF. AT THE SAME TIME, THE BATTERY SCREW-ON RETAINER CAP BEGIN TO GET HOT. NO REPORT OF USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37161 RUSCH FIBEROPTIC LARYNGOSCOPE HANDLE, SMALL LARYNGOSCOPE HANDLE CCW TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1