BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 5015166 · Received August 19, 2015

    Report

    Report Number
    1044475-2015-00311
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 30, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT THE GOLD PIPE LIGHT AND BULB BASE WERE DETACHED FROM THE BLADE. NO OBVIOUS DAMAGE NOTED VISUALLY. THE GOLD PIPE LIGHT WAS RE-INSTALLED ONTO THE BLADE WITH NO FITTING OR ALIGNMENT ISSUES NOTED. THE BLADE WAS ATTACHED TO A KNOWN GOOD HANDLE AND FITTING/ALIGNMENT WAS NOT AN ISSUE. IT WAS NOTED THAT THE LIGHT WAS NOT BURNING AFTER THE BLADE WAS ENGAGED. AFTER FURTHER INVESTIGATION IT WAS DETERMINED THE SMALL INCANDESCENT BULB WAS BURNED OUT. THE ORIGINAL COMPLAINT OF THE PIPE LIGHT NOT FITTING ONTO THE BLADE CANNOT BE CONFIRMED. THE COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE ESTABLISHED. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HAVING DIFFICULTY REASSEMBLING THE GOLD PIPE LIGHT ONTO THE BLADE. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548046 RUSCH MRI COND FIBER OPTIC LARYN KIT LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1