BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN RUSCHLITE DISP MTL MILL 3

    MDR report key: 6858787 · Received September 12, 2017

    Report

    Report Number
    8030121-2017-00129
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 24, 2017
    Report Date
    August 24, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "PHYSICIAN USING THE GRL BLADE HAD TIP OF BLADE BREAK OFF RIGHT WHERE THE GREEN SLEEVE STARTS ON THE GRL MILLER 3 BLADE. PIECE OF FIBEROPTIC LIGHT PIPE WAS RECOVERED AND NONE IS SUSPECTED TO BE CURRENTLY IN PATIENT. " IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "PHYSICIAN USING THE GRL BLADE HAD TIP OF BLADE BREAK OFF RIGHT WHERE THE GREEN SLEEVE STARTS ON THE GRL MILLER 3 BLADE. PIECE OF FIBEROPTIC LIGHT PIPE WAS RECOVERED AND NONE IS SUSPECTED TO BE CURRENTLY IN PATIENT. " IT WAS REPORTED THERE WAS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639505 GREEN RUSCHLITE DISP MTL MILL 3 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1