BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFIT CORONET

    MDR report key: 1435616 · Received August 6, 2009

    Report

    Report Number
    1435616
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Date of Event
    July 20, 2009
    Report Date
    August 6, 2009
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Product Code
    HNN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CENTER BLACK RING USED TO ADVANCE THE BLADE ON THE TREPHINE WAS NOT GLUED IN WELL AND DETACHED FROM THE TREPHINE. THIS IS A COMMON OCCURRENCE AND SOMETIMES AS MANY AS 5 DEVICES ARE USED BEFORE AN UNAFFECTED DEVICE IS FOUND.

    Description of Event or Problem · 1

    THE CENTER BLACK RING USED TO ADVANCE THE BLADE ON THE TREPHINE WAS NOT GLUED IN WELL AND DETACHED FROM THE TREPHINE. THIS IS A COMMON OCCURRENCE AND SOMETIMES AS MANY AS 5 DEVICES ARE USED BEFORE AN UNAFFECTED DEVICE IS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFIT CORONET KNIFE, OPHTHALMIC HNN SURGICAL SPECIALTIES CORP. * 081577&081916&081703(3) CONT.

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES| NO OTHER THERAPIES