BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ ILLUM, 3.5MM X 8' PILLING INSTR

    MDR report key: 19374934 · Received May 22, 2024

    Report

    Report Number
    3011137372-2024-00082
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 25, 2024
    Report Date
    April 25, 2024
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EQH
    UDI-DI
    14026704658685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING DIRECT LARYNGOSCOPY, WHILE USING THE PHILLING LIGHT CORD WHICH WAS PLUGGED INTO THE ARTHREX LIGHT SOURCE, STAFF IN THE OPERATING ROOM SMELLED A BURNING SMELL. SUBSEQUENTLY, WE REMOVED THE LIGHT CORD AND FOUND THAT THE TIP OF THE LIGHT CORD THAT ENTERS INTO THE LIGHT SOURCE HAD BEEN BURNT. THE TIP OF THE CORD WITH THE FIBERS WERE BURNT AS WELL.PATIENT SEEMED UNAFFECTED AND EQUIPMENT WAS TURNED OFF, REMOVED, AND TAGGED FOR FURTHER INVESTIGATION. SURGEON, PROCEEDED TO DO A VOCAL CORD LESION EXCISION, BY MICROSCOPE AND DID NOT SEE ANY HARM TO AIRWAY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING DIRECT LARYNGOSCOPY, WHILE USING THE PHILLING LIGHT CORD WHICH WAS PLUGGED INTO THE ARTHREX LIGHT SOURCE, STAFF IN THE OR SMELLED A BURNING SMELL.SUBSEQUENTLY, WE REMOVED THE LIGHT CORD AND FOUND THAT THE TIP OF THE LIGHT CORD THAT ENTERS INTO THE LIGHT SOURCE HAD BEEN BURNT. THE TIP OF THE CORD WITH THE FIBERS WERE BURNT AS WELL.PATIENT SEEMED UNAFFECTED AND EQUIPMENT WAS TURNED OFF, REMOVED, AND TAGGED FOR FURTHER INVESTIGATION. SURGEON, PROCEEDED TO DO A VOCAL CORD LESION EXCISION, BY MICROSCOPE AND DID NOT SEE ANY HARM TO AIRWAY.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451987 STORZ ILLUM, 3.5MM X 8' PILLING INSTR SOURCE, CARRIER, FIBEROPTIC LI EQH TELEFLEX MEDICAL 1839-07 14026704658685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown