BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 701350 · Received March 24, 2006

    Report

    Report Number
    701350
    Event Type
    Other
    Date Received
    March 24, 2006
    Date of Event
    March 23, 2006
    Report Date
    March 24, 2006
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC.
    Product Code
    KNW
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    A PIECE OF THE BIOPSY FORCEPS LODGED IN PATIENT'S BRAIN DURING SURGERY. PIECE MAY BE IN BRAIN OR SOFT TISSUE. INJURY TO PATIENT, UNKNOWN, PATIENT TO RECEIVE POST OP MRI. UPON INSPECTION THE SCREW TO ATTACH THE OPENING MECHANISM TO THE FORCEP TIP IS MISSING. FROM THE EXAMINATION IT LOOKS LIKE THE OPENING MECHANISM MAY HAVE BEEN SLIGHTLY BENT CAUSING THE SCREW TO COME OUT. THIS DOES NOT APPEAR TO BE A MANUFACTURING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BIOPSY FORCEPS KNW KARL STORZ ENDOSCOPY AMERICA, INC. 28162 PL FG 01 RB

    Patients

    Seq Age Sex Outcome Treatment
    1 *