BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEDO LASER MICRO LARYNGOSCOPE

    MDR report key: 5242486 · Received November 23, 2015

    Report

    Report Number
    1044475-2015-00384
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    October 30, 2015
    Report Date
    November 2, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER BUT THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT# AS REPORTED BY CUSTOMER: AA6. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 522228. (1) SAMPLE OF 522228 (LOT AA6 - JANUARY OF 1996) WAS RECEIVED FOR EVALUATION. THE DEVICE IS BROKEN WHERE THE HANDLE IS FUSED TO THE INSERTABLE SCOPE, DUE TO THE AGE OF THE DEVICE >10 YEARS OLD. THE DEVICE HAS EXCEEDED IT'S EXPECTED LIFE. NO FURTHER INVESTIGATION IS REQUIRED. THE DEVICE IS NOT REPAIRABLE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE LARYNGOSCOPE BROKE AFTER INSERTION INTO THE PATIENT DURING THE LIFT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE LARYNGOSCOPE BROKE AFTER INSERTION INTO THE PATIENT DURING THE LIFT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774783 DEDO LASER MICRO LARYNGOSCOPE LARYNGOSCOPE,RIGID CCW TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1