BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARDY CURETTE

    MDR report key: 583643 · Received March 14, 2005

    Report

    Report Number
    583643
    Event Type
    Other
    Date Received
    March 14, 2005
    Date of Event
    March 7, 2005
    Report Date
    March 14, 2005
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    HTF
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD AN ABNORMALITY OF THE SPHENOID SINUS NOTED ON A CT AND AN MRI. THE PATIENT HAD A HISTORY OF LEIMYOSARCOMA OF THE RETROPERITONEUM. THE MASS WAS BIOPSIED USING A TRANSSEPTAL APPROACH. DURING THE PROCEDURE A 3 MM TRANSPHENOIDAL CURETTE WAS USED. THE TIP BROKE OFF OF THE CURETTE AND THE OPERATING SURGEON WAS UNABLE TO LOCATE IT. A C-ARM WAS BROUGHT IN, BUT FOLLOWING THE X-RAY THE TIP WAS FOUND ON THE DRAPE. THE X-RAY SHOWED NOTHING WAS INSIDE THE PATIENT. THE PATIENT WAS DETERMINED TO BE UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARDY CURETTE CURETTE HTF CODMAN AND SHURTLEFF, INC. 80-1346 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR