BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC PLUS METZENBAUM SCISSOR

    MDR report key: 4963915 · Received July 30, 2015

    Report

    Report Number
    3007208013-2015-00014
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 9, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (METZ SCISSORS) WAS EVALUATED BY OUR CONTRACT SUPPLIER, SUPPLIER STATED: THE HARDNESS IS IN THE CENTRAL REGION AND THE MICROSCOPIC EXAMINATION SHOWED A FLAWLESS STRUCTURE. THE BREAK CAN BE CAUSED ONLY BY EXCESSIVE STRESS. ALL MATERIALS AND HARDNESS ARE TO THE CORRECT SPEC.

    Description of Event or Problem · 1

    THE SCISSOR BROKE INTO TWO PIECES DURING A PROCEDURE, NO PATIENT HARM. 10 MIN DELAY IN SURGERY UNTIL A NEW INSTRUMENT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498884 CLASSIC PLUS METZENBAUM SCISSOR SCISSOR LRW SYMMETRY SURGICAL INC. 36-5016

    Patients

    Seq Age Sex Outcome Treatment
    1