BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLED HANDLE, MEDIUM

    MDR report key: 7416897 · Received April 10, 2018

    Report

    Report Number
    8030121-2018-00040
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 19, 2018
    Report Date
    March 19, 2018
    Manufacturer
    TRUPHATEK INTERNATIONAL LTD.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE SAMPLE WAS RETURNED TO THE MANUFACTURER (TRUPHATEK) FOR EVALUATION. THE MANUFACTURER REPORTS THAT THE HANDLE WAS WORKING PROPERLY. NO LIGHTING AND FLICKERING ISSUE WERE OBSERVED, AND THE LIGHT WAS COMPLETELY STABLE. THE COMPLAINT OF FLICKERING COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD WAS PERFORMED ON THE LOT NUMBER OF THE SAMPLE RECEIVED (170401) AND NO ISSUES WERE FOUND. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE LIGHT FLICKERS." ALLEGED DEFECT REPORTED AS DETECTED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE LIGHT FLICKERS." ALLEGED DEFECT REPORTED AS DETECTED PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257855 RUSCH GREENLED HANDLE, MEDIUM LARYNGOSCOPE, RIGID CCW TRUPHATEK INTERNATIONAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1