BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLINE

    MDR report key: 8213965 · Received January 3, 2019

    Report

    Report Number
    1314417-2018-00061
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 10, 2018
    Report Date
    February 1, 2019
    Manufacturer
    MEDICAL DEVICES
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE DATE OF REPORT WAS ENTERED INCORRECTLY ON THE CUSTOMER COMPLAINT FORM THEREFORE IT WAS REPORTED INCORRECTLY WHEN THE INITIAL MDR WAS SUBMITTED. EVALUATION SUMMARY: RETURNED HANDLE PENLITE (5-0236-90) LOT # RD WAS RETURNED WITH BATTERIES INSTALLED FROM THE CUSTOMER. WHEN THE LED LIGHT WAS DEPRESSED WITH A MILLER SIZE 0 BLADE THE LIGHT DID FLICKER. HOWEVER, WHEN THE HANDLE WAS DISASSEMBLED IT WAS VISUALLY NOTICED THAT THE LED CARTRIDGE HAD BEEN REMOVED WITH A TOOL AS THERE WAS DAMAGE TO THE ORANGE PLASTIC (SEE ATTACHED PICTURE). IT WAS ALSO DISCOVERED THAT THE LED CARTRIDGE ASSEMBLY WAS NOT FULLY TIGHTENED IN THE ASSEMBLY SO THE LED CARTRIDGE WAS TURNED ¼ TURN BY HAND TO FULLY TIGHTEN. AFTER THE PROPER INSTALLATION OF THE LED CARTRIDGE WAS COMPLETED, THE HANDLE WAS REASSEMBLED AND THE SAME CUSTOMER SUPPLIED BATTERIES WERE USED TO ILLUMINATE THE LED LIGHT. THE LIGHT NO LONGER FLICKERED. THE HANDLE WAS ROTATED, SHOCK, AND EVEN DROPPED FROM A HEIGHT OF 24 INCHES WITH THE MILLER SIZE 0 BLADE INSTALLED AND THE LED LIGHT STAYED ILLUMINATED, NO FLICKERING. THE FLICKERING LIGHT WAS DUE TO THE LED CARTRIDGE NOT BEING FULLY THREADED BACK INTO POSITION BY THE CUSTOMER AFTER STERILIZATION. RETURNED HANDLE MEDIUM (5-0236-99) LOT # SG WAS RETURNED WITHOUT BATTERIES INSTALLED. NEW BATTERIES WERE INSTALLED AND THE HANDLE ILLUMINATED AS EXPECTED WHEN A MILLER SIZE 0 BLADE WAS INSTALLED. THE HANDLE WAS ROTATED, SHOCK, AND EVEN DROPPED FROM A HEIGHT OF 24 INCHES WITH THE MILLER SIZE 0 BLADE INSTALLED AND THE LED LIGHT STAYED ILLUMINATED, NO FLICKERING. THE LED CARTRIDGE WAS REVIEWED WHEN NEW BATTERIES WERE INSTALLED AND IT DID NOT EXHIBIT ANY MIS-USE AND WAS FULLY THREADED INTO POSITION. THIS RETURNED HANDLE FUNCTIONED AS INTENDED AND DID NOT EXHIBIT ANY FLICKERING.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGES THAT "LIGHT FLICKERING ON HANDLE." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Additional Manufacturer Narrative · 1

    NO CUSTOMER PRODUCT WAS AVAILABLE FOR TESTING. AN INVENTORY EVALUATION WAS PERFORMED TO CHECK FOR REPORTED DEFECT IN HOUSE. NO SAMPLES FROM EVALUATION HAD ANY ISSUES WITH FLICKERING. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "LIGHT FLICKERING ON HANDLE." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4833 GREENLINE LARYNGOSCOPE CCW MEDICAL DEVICES 5-0236-90 RD

    Patients

    Seq Age Sex Outcome Treatment
    1