BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC STUBBY HANDLE

    MDR report key: 5786668 · Received July 12, 2016

    Report

    Report Number
    3011137372-2016-00216
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 30, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT THE STUBBY HANDLE WAS VISUALLY INSPECTED AND NO SIGNS OF ABUSE/MISUSE OR DAMAGE NOTED. SAMPLE LOT# 142501. A GREEN RUSCH LITE MILLER 3 FIBER OPTIC, SINGLE USE BLADE WAS ATTACHED TO THE HANDLE AND ENGAGED. UPON ENGAGEMENT THE LIGHT IN THE STUBBY HANDLE FLICKERED. THE STUBBY HANDLE WAS DISASSEMBLED IN ORDER TO INSPECT THE LIGHT CHAMBER ASSEMBLY. UPON INSPECTION A LOOSE BULB WAS DISCOVERED. THE BULB WAS BACKED OUT OF THE "TIGHT" SEATING POSITION BY APPROXIMATELY TWO AND ONE HALF TURNS. THIS CONDITION COULD CAUSE THE BULB TO NOT ENERGIZE AT ALL, AND WOULD CERTAINLY CAUSE A FLICKERING CONDITION UPON BLADE ENGAGEMENT. THE COMPLAINT HAS BEEN CONFIRMED. ROOT CAUSE IS ASSOCIATED WITH A LACK OF GOOD "PRIOR TO USE" INSPECTION AND MAINTENANCE PROTOCOL. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. REFERENCE IFU CARE AND MAINTENANCE INSTRUCTIONS FOR RUSCH LARYNGOSCOPE HANDLES AND BLADES, BLADES AND HANDLES TEST PROCEDURES, "LARYNGOSCOPE BLADES AND HANDLES SHOULD ALWAYS BE TESTED AFTER CLEANING/DISINFECTION/STERILIZATION AND PRIOR TO USE. TO TEST, CONNECT THE LARYNGOSCOPE BLADE TO THE HANDLE AND PULL UP TO ON POSITION. IF THE UNIT FAILS TO LIGHT OR FLICKERS CHECK THE LAMP, BATTERIES AND THE ELECTRICAL CONTACTS". NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE LIGHT FLICKERED DURING INTUBATION. NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438965 RUSCH GREENSPEC STUBBY HANDLE LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1