BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD KNIFE STRAIGHT BLADE

    MDR report key: 381344 · Received March 6, 2002

    Report

    Report Number
    1519132-2002-00019
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Date of Event
    February 13, 2002
    Report Date
    March 6, 2002
    Manufacturer
    CIRCON ACMI
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLADE BROKE OFF IN PATIENT DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD KNIFE STRAIGHT BLADE 500 GDX CIRCON ACMI K-SB BD (2/00)

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO