BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FO HANDLE MEDIU

    MDR report key: 7352425 · Received March 20, 2018

    Report

    Report Number
    8030121-2018-00031
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 2, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM AND FUNCTIONAL TESTING WERE PERFORMED AND THERE WERE NO ISSUES FOUND. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION AND FUNCTIONED PROPERLY. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT NUMBER OF THE SAMPLE RECEIVED (170401) AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "REUSABLE FIBER OPTIC HANDLE AND REUSABLE EMERALD LARYNGOSCOPE BLADE ARE "STUCK" IN THE LOCKED/ENGAGED POSITION". ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. CUSTOMER REPORTS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE'. NO REPORT OF USER HARM. (EMERALD LARYGOSCOPE BLADE DEVICE CAPTURED IN COMPANION REPORT.)

    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 INVESTIATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "REUSABLE FIBER OPTIC HANDLE AND REUSABLE EMERALD LARYNGOSCOPE BLADE ARE "STUCK" IN THE LOCKED/ENGAGED POSITION". ALLEGED MALFUNCTION REPORTED AS OCCURRING DURING USE. CUSTOMER REPORTS NO INJURY OR CONSEQUENCE TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE'. NO REPORT OF USER HARM. (EMERALD LARYNGOSCOPE BLADE DEVICE CAPTURED IN COMPANION REPORT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196686 RUSCH GREENSPEC FO HANDLE MEDIU LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 170401

    Patients

    Seq Age Sex Outcome Treatment
    1 EMERALD LARYGOSCOPE BLADE| EMERALD LARYGOSCOPE BLADE