BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLED HANDLE, MEDIUM

    MDR report key: 13846393 · Received March 22, 2022

    Report

    Report Number
    8030121-2022-00010
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 2, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS: "WE INSPECTED THE COMPLAINT DEVICE AND FOUND THAT THE BOTTOM CAP OF THE COMPLAINT DEVICE WAS LOOSE AND NOT TIGHTENED PROPERLY THAT COULD BE CONTRIBUTE FOR LIGHT FLICKERING OF HANDLES AND BLADES. DURING FUNCTIONAL TESTING OF COMPLAINT DEVICE, IT WAS IDENTIFIED THAT THE BOTTOM CAP OF THE HANDLE WAS IN LOOSE CONDITION AND NOT MOUNTED PROPERLY, SO FIRSTLY WE TIGHTENED THE BOTTOM CAP PROPERLY AND PERFORMED THE TESTING OF HANDLE AND BLADE, AND WE HAVE OBSERVED THAT COMPLAINT SAMPLE WAS WORKING FINE AND LIGHT FROM THE BLADE WAS CONSTANT AND BLOWING PERFECTLY. THE DEVICE HISTORY RECORD FOR LOT CODE 160702 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE ROOT CAUSE OF THIS COMPLAINT IS DEEMED AN UNINTENTIONAL USER-RELATED ERROR BECAUSE IN THE INVESTIGATION IT HAS BEEN IDENTIFIED THAT THE USER HAD NOT TIGHTENED THE BOTTOM CAP OF THE HANDLE PROPERLY, THEREFORE THE CUSTOMER HAD COUNTERED THE LIGHT FLICKERING ISSUE OF THE HANDLE." IN ADDITION, THE CUSTOMER USED THE PRODUCT BEYOND ITS MATERIAL LIFE OF 5 YRS.

    Additional Manufacturer Narrative · 0

    QN#(B)(4) CORRECTED DATA: SECTION D.9.-ADDED DEVICE RETURNED ON DATE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WITH THE HANDLE, THE LIGHT KEEPS FLICKERING, SO A NEW HANDLE HAD TO BE TAKEN". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WITH THE HANDLE, THE LIGHT KEEPS FLICKERING, SO A NEW HANDLE HAD TO BE TAKEN". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WITH THE HANDLE, THE LIGHT KEEPS FLICKERING, SO A NEW HANDLE HAD TO BE TAKEN". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32880 RUSCH GREENLED HANDLE, MEDIUM LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 160702

    Patients

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