BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFFIER

    MDR report key: 5127970 · Received September 29, 2015

    Report

    Report Number
    3007208013-2015-00024
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    DWS
    UDI-DI
    00887482079379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SYMMETRY SURGICAL RECEIVE THE DEVICE BACK FROM THE CUSTOMER ON 09/09/2015, THE DEVICE WAS VISUALLY INSPECTED AND DETERMINED THE DEVICE HAD BEEN USED BEYOND ITS INTENDED LIFE. THE DEVICE WAS PURCHASED PRIOR TO 2011 FROM ANOTHER COMPANY. CUSTOMER DID NOT WANT A REPLACEMENT FOR THE BROKEN DEVICE.

    Description of Event or Problem · 1

    THE SURGEON MADE AN INCISION ALONG THE POSTERIOR AXILLARY LINE, APPROX 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-DIA 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 IRRIGATED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SOLUTION. TWO CHEST TUBES WERE PLACED. THE PT TOLERATED THE PROCEDURE WELL AND WEN TO CV INTENSIVE C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642451 TUFFIER RIB SPREADER DWS SYMMETRY SURGICAL INC. 54-2242 00887482079379

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR