BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLD KNIFE, STRAIGHT BLADE

    MDR report key: 473926 · Received July 22, 2003

    Report

    Report Number
    1519132-2003-00024
    Event Type
    Malfunction
    Date Received
    July 22, 2003
    Date of Event
    June 27, 2003
    Report Date
    June 27, 2003
    Manufacturer
    ACMI NORWALK
    Product Code
    GDX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    "DURING PROCEDURE, BLADE BROKE OFF INSIDE PATIENT. RETRIEVED BY DR. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLD KNIFE, STRAIGHT BLADE URETHROTOME ACCESSORY GDX ACMI NORWALK K-SB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN