BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 2181985 · Received June 16, 2011

    Report

    Report Number
    2647580-2011-00415
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 12, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC LEFT HEMICOLECTOMY. ACCORDING TO THE REPORTER: IN USE, THE ABDOMEN WAS OPENED WITH A SMALL WOUND AND THE DEVICE WAS SET, THEN WHEN INSUFFLATION OF THE ABDOMINAL CAVITY WAS DONE, THE BALLOON WAS TORN. ANOTHER DEVICE WAS USED. NO BLEEDING OCCURRED. NOTHING FELL INTO THE PT CAVITY. NO TISSUE WAS DAMAGED. OPERATIVE TIME WAS NOT EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR 12MM DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P1B0624

    Patients

    Seq Age Sex Outcome Treatment
    1