BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 1003772 · Received February 22, 2008

    Report

    Report Number
    2647580-2008-00084
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 6, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: ONE OF THE SCREWS FELL OUT FROM THE LOCKING COLLAR AND THE DEVICE WOULD NOT STAY IN THE LOCKED POSITION. THE PIN DID NOT FALL INTO THE PATIENT'S CAVITY. REMOVED THE TROCAR AND USED A NEW ONE. NO INJURY REPORTED. OR TIME WAS DELAYED APPROXIMATELY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER STRUCTURAL BALLOON TROCAR DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7F0299

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK