BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFFIER

    MDR report key: 5096447 · Received September 23, 2015

    Report

    Report Number
    5096447
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYMMETRY SURGICAL, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON MADE AN INCISION ALONG THE POSTERIOR AXILLARY LINE, APPROXIMATELY THE FIFTH INTERSPACE CARRIED DOWN THROUGH VARIOUS LAYERS WITH ELECTROCAUTERY. THE LUNG WAS DEFLATED AND THE CHEST WAS ENTERED. THE SCOPE WAS PLACED. ADHESION WAS BROKEN UP WITH THORASCOPE. THE SCOPE WAS THEN REMOVED. THE INCISION WAS OPENED TO A THORACOTOMY. PARTIAL PLEURECTOMY AND TOTAL DECORTICATION WAS PERFORMED. BRONCHOPLEURAL (BP) FISTULA WAS WEDGED WITH ENDO-GIA STAPLING DEVICE. TUFFIER RETRACTOR WAS IN THE LEFT CHEST. TO DETRACT INCISION AND REMOVE TUFFIER, THE KNOB NEEDED TO TURN AND RETRACTOR BROKE OFF. THE SURGEON HAD TO EXTEND THE INCISION TO REMOVE THE TUFFIER RETRACTOR. THE CHEST WAS TOTALLY IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SOLUTION. TWO CHEST TUBES WERE PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WENT TO CV INTENSIVE CARE UNIT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627858 TUFFIER SPREADER, RIB GAD SYMMETRY SURGICAL, INC. 54-2242

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other