BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP MTL MAC 4

    MDR report key: 10259672 · Received July 10, 2020

    Report

    Report Number
    8030121-2020-00097
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RECEIVED AND RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE MANUFACTURING SITE REPORTS THAT THE DIMENSIONS OF THE BLADE WERE VERIFIED AND FUNCTIONAL TESTING WAS PERFORMED. THE BLADE WAS WORKING PERFECTLY AND WAS STABLE ON THE HANDLE. IT WAS ALSO REPORTED THAT THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT NO. 2002341 AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE RETURNED BLADE WAS FOUND TO MEET MANUFACTURING RELEASE SPECIFICATIONS AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "LARYNGOSKOPE BLADE IS NOT STABLE IN ITS HANDLE (RUSCH) AND DUE TO THIS THE BLADE MOVES DURING INTUBATION." IT WAS REPORTED THE ISSUE WAS DISCOVERED PRIOR TO PATIENT USE AND THE DEVICE WAS NOT USED FOR INTUBATION BECAUSE IT WAS OBVIOUS THAT THE LARYNGOSCOPE WAS NOT STABLE IN IT'S HANDLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LARYNGOSKOPE BLADE IS NOT STABLE IN ITS HANDLE (RUSCH) AND DUE TO THIS THE BLADE MOVES DURING INTUBATION." IT WAS REPORTED THE ISSUE WAS DISCOVERED PRIOR TO PATIENT USE AND THE DEVICE WAS NOT USED FOR INTUBATION BECAUSE IT WAS OBVIOUS THAT THE LARYNGOSCOPE WAS NOT STABLE IN IT'S HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721035 RUSCH GREENLITE DISP MTL MAC 4 LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 2002341

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.