BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLENGER SWIVEL KNIFE

    MDR report key: 4118836 · Received July 30, 2014

    Report

    Report Number
    3007208013-2014-00010
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 29, 2014
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NO PATIENT INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE BLADE CAME OFF DURING A SINUS SURGERY. THE BLADE STUCK IN THE SINUS CAVITY. THERE WAS NO HARM DONE TO THE PATIENT. THE SURGEON CHOSE NOT TO PROCEED WITH THE SURGERY. THE INSTRUMENT WAS THROWN AWAY BY THE FACILITY. NO PHOTOS WERE PROVIDED. THERE IS NO RECORD OF PURCHASE. THE MANUFACTURER COULD NOT BE VERIFIED. THE REPORTER (MATERIALS MANAGER) ADVISED THAT THE INSTRUMENT WAS 8-10 YEARS OLD. THE INSTRUMENT HAS BEEN USED BEYOND THE EXPECTED LIFETIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445797 BALLENGER SWIVEL KNIFE SWIVEL KNIFE KTG SYMMETRY SURGICAL 66-5015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1