BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOOKWALTER MAILABLE RETRACTOR BLADE 3X6

    MDR report key: 3772344 · Received December 18, 2013

    Report

    Report Number
    3007208013-2013-00020
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    December 18, 2013
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE BOOKWALTER BLADE WAS BROKEN AT THE WELD WHERE THE SHAFT ATTACHES TO THE BLADE. ACCORDING TO JANET BRANSCOME, RISK MANAGER AT (B)(6), THERE WAS NO HARM TO THE PATIENT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664291 BOOKWALTER MAILABLE RETRACTOR BLADE 3X6 MAILABLE RETRACTOR BLADE 3X6 GEI SYMMETRY SURGICAL 50-4567 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other