BEUDAMED
    FDA Adverse Event Summary report: N

    GREENBERG

    MDR report key: 4364510 · Received December 1, 2014

    Report

    Report Number
    3007208013-2014-00018
    Date Received
    December 1, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 6, 2014
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ACTUAL DEVICE NOT EVALUATED.

    Description of Event or Problem · 1

    (B)(6), SURGICAL MATERIALS DEPT. TECH REPORTED: DURING PROCEDURE SURGEON ATTEMPTED TO MAKE A POSITIONAL ADJUSTMENT OF RETRACTION ARM HOLDING RETRACTOR BLADE TO PATIENT'S BRAIN. THE ARMATURE'S HANDLE BAR BECAME STUCK IN EYE OF TIGHTENING BOLT, WHEN IT SUDDENLY CAME LOOSE. RETRACTOR BLADE SLIPPED AND MADE AN UNPLANNED CUT ON BRAIN. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED THAT I WAS AWARE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776202 GREENBERG SHORT ARM RETRACTOR GZT SYMMETRY SURGICAL INC. 50-1511 3093

    Patients

    Seq Age Sex Outcome Treatment
    1