BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENLITE DISP METAL MILLER 1 BLADE

    MDR report key: 10707784 · Received October 20, 2020

    Report

    Report Number
    8030121-2020-00151
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 29, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). MEDWATCH RECEIVED - MW5096092. THE CUSTOMER RETURNED ONE RUSCH GREENLITE DISPOSABLE MILLER 1 BLADE FOR EVALUATION. VISUAL INSPECTION OF THE BLADE CONFIRMED THAT THE LIGHT PIPE WAS BROKEN. THE DEVICE HISTORY RECORD OF LOT 1812411 WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE COMPLAINT OF A BROKEN LIGHT PIPE HAS BEEN CONFIRMED BY THIS COMPLAINT INVESTIGATION. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. A CAPA HAS ALREADY BEEN ISSUED TO FURTHER INVESTIGATE THIS ISSUE. IT HAS BEEN DETERMINED UNDER THIS CAPA THAT THE ROOT CAUSE IS PACKAGING RELATED.

    Description of Event or Problem · 0

    THE COMPLAINT WAS RECEIVED VIA MEDWATCH. "LIGHT SOURCE OF BLADE BROKE OFF DURING DIRECT LARYNGOSCOPY, VISUALIZED IN OROPHARYNX AND RETRIEVED WITHOUT DIFFICULTY.". ADDITIONAL INFORMATION WAS RECEIVED BY THE USER FACILITY INDICATING THE PART WAS RETRIEVED FROM THE OROPHARYNX WITHOUT DIFFICULTY. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT HAD NO HARM FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED VIA MEDWATCH. "LIGHT SOURCE OF BLADE BROKE OFF DURING DIRECT LARYNGOSCOPY, VISUALIZED IN OROPHARYNX AND RETRIEVED WITHOUT DIFFICULTY." ADDITIONAL INFORMATION WAS RECEIVED BY THE USER FACILITY INDICATING THE PART WAS RETRIEVED FROM THE OROPHARYNX WITHOUT DIFFICULTY. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT HAD NO HARM FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173624 RUSCH GREENLITE DISP METAL MILLER 1 BLADE LARYNGOSCOPE, RIGID CCW TELEFLEX MEDICAL 1812411

    Patients

    Seq Age Sex Outcome Treatment
    1 LARYNGOSCOPE HANDLE.| LARYNGOSCOPE HANDLE.