BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACOPORT 11.5MM TROCAR

    MDR report key: 1193201 · Received October 7, 2008

    Report

    Report Number
    2647580-2008-00590
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 30, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K992288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: THORACOSCOPY. ACCORDING TO THE REPORTER: THE PORT BROKE IN HALF DURING INSTRUMENT EXCHANGE. SURGEON HAD TO GO IN AND RETRIEVE HALF OF THE PORT FROM THE PATIENT'S CAVITY. ALL PIECES WERE RETRIEVED. A NEW PORT WAS OPENED AND INSERTED TO FINISH THE CASE. DELAY IN OR WAS 10 MINUTES. NO BLEEDING OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORACOPORT 11.5MM TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8C1007

    Patients

    Seq Age Sex Outcome Treatment
    1