BEUDAMED
    FDA Adverse Event Other Summary report: N

    PASSPORT TROCAR

    MDR report key: 2176771 · Received July 14, 2011

    Report

    Report Number
    1651380-2011-00001
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PATTON SURGICAL CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K080161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL UNITS TESTED WERE IN ORIGINAL, SINGLE UNIT, UNOPENED PACKAGES. EACH CANNULA TUBE ASSEMBLY WAS SECURED INTO A TEXT FIXTURE, AT 30 DEGREES RELATIVE TO VERTICAL, AND FORCE WAS APPLIED AT A RATE OF 12 IN/MIN TO THREE LOCATIONS ALONG THE CANNULA TUBE; PROXIMAL, CENTER AND DISTAL USING A CHARTILLON PCM 2001 AND BG100RT LOAD CELL. NO UNITS SHATTERED UNDER THE DYNAMIC LOAD APPLIED, AT EITHER THE PROXIMAL, CENTER OR DISTAL LOCATIONS EVALUATED. DETAILED TEST DATA IS ON FILE AT PATTON SURGICAL CORPORATION.

    Description of Event or Problem · 1

    WHEN THE THORASCOPIC CAMERA PORT WAS REMOVED, STAFF OBSERVED THAT THE LAPAROSCOPIC TROCAR SHATTERED. SURGEON WAS ABLE TO RETRIEVE 2 BROKEN PIECES OF THE PORT FROM THE THORACIC CAVITY; UNABLE TO FIND 3RD PIECE (APPROX 5MM X 1CM). LEFT HEMITHORAX WAS THOROUGHLY INSPECTED AND PIECE NOT FOUND. CHEST X-RAY NEGATIVE. PIECE NOT RADIO-OPAQUE. PIECE NOT LOCATED AFTER SEARCH IN OPERATING ROOM. SURGEON EXPLAINED IF PIECE RETAINED, NO HARM TO PATIENT. ORIGINAL INTENDED PROCEDURE: FLEXIBLE BRONCHOSCOPY, ENDOBRONCHIAL ULTRASOUND, TRANSBRONCHIAL NEEDLE ASPIRATION, MEDIASTINOSCOPY, VIDEO ASSISTED THORASCOPY, LEFT LOWER LOBE LOBECTOMY, LYMPH NODE DISSECTION, INTERCOSTAL NERVE BLOCK FOR LUNG CA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT TROCAR PLASTIC TROCAR GCJ PATTON SURGICAL CORP. 12100ES-11 8096-01

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR