BEUDAMED
    FDA Adverse Event Summary report: N

    KERRISON RONGEUR

    MDR report key: 2517578 · Received March 19, 2012

    Report

    Report Number
    2517578
    Date Received
    March 19, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 19, 2012
    Manufacturer
    AESCULAP, INC.
    Product Code
    HAE
    Report Source
    User Facility report
    Reporter Location
    MS, US

    Narratives

    Description of Event or Problem · 1

    A LUMBAR LAMINECTOMY TRAY WAS OPENED IN THE OR SUITE AND IT WAS NOTED THE KERRISON RONGEUR HAD TRIED BONE IN THE TIP OF THE INSTRUMENT. THIS PARTICULAR MODEL DOES NOT COME APART. THE INSTRUMENT HAD BEEN CLEANED PRIOR TO THE PROCEDURE PER THE MANUFACTURER'S RECOMMENDATIONS. THERE ARE NO SPECIAL CLEANING TOOLS THAT ARE PROVIDED WITH THIS DEVICE. THIS INSTRUMENT DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR RONGEUR HAE AESCULAP, INC. AESCULAP FF 661R *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES