BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE MYRINGOTOMY KNIFE

    MDR report key: 1615199 · Received February 23, 2010

    Report

    Report Number
    1037007-2010-00002
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 23, 2010
    Manufacturer
    GYRUS ENT LLC
    Product Code
    JYP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS PACKAGED WITH A TIP PROTECTOR TO PROTECT THE SHARP END WHILE PACKAGED AND WHILE REMOVING FROM PACKAGING. THE DESCRIPTION FROM THE USER INDICATES THAT THE KNIFE HAD BEEN IN USE AND WAS BEING HANDLED. THERE IS NO INDICATION OF A MALFUNCTION OR DEFECT. NO OTHER REPORTS FOR THIS LOT. LOT IS NO LONGER ON HAND. NO OTHER REPORTS FOR THIS ITEM FOR THE LAST 4 YEARS.

    Description of Event or Problem · 1

    CUT FINGER, BLOOD BORNE PATHOGEN EXPOSURE. NURSE WAS ASSISTING WITH SCRUB IN OPERATING ROOM DURING A BMT PROCEDURE, THE SURGEON PUT DOWN THE MYRINGOTOMY KNIFE AND THE NURSE WENT TO PUT THE KNIFE BACK AND STRUCK HERSELF IN THE FINGER WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MYRINGOTOMY KNIFE JYP GYRUS ENT LLC 0925221063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention