BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT 12MM CANN/DILATOR W/RAD EXPAND SLV

    MDR report key: 1962924 · Received December 22, 2010

    Report

    Report Number
    2647580-2010-00998
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 26, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K961430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: THORACOSCOPY. ACCORDING TO THE REPORTER: DURING THE CASE WHEN THE SURGEON INSERTED THE TROCAR; THE BOTTOM PORTION OF DILATOR SNAPPED OFF IN PT. SURGEON WAS ABLE TO REMOVE SNAPPED PORTION. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHORT 12MM CANN/DILATOR W/RAD EXPAND SLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0H0890

    Patients

    Seq Age Sex Outcome Treatment
    1