BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 12MM ST W/ FIXATION

    MDR report key: 1830035 · Received September 3, 2010

    Report

    Report Number
    1219930-2010-00692
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    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: LAP GASTRIC BYPASS. ACCORDING TO THE RPTR: AFTER INSERTION, IT WAS NOTICED THAT A PIECE HAD BROKEN OFF FROM THE TROCAR AND WAS IN THE PT'S CAVITY. THE PIECE WAS A 2MM LENGTH TIP OF THE WHITE TROCAR. THE SURGEON WAS ABLE TO REMOVE THE PIECE FROM THE CAVITY. THE CASE WAS COMPLETE AT THIS POINT. THERE WAS NO REPORT OF UNANTICIPATED BLOOD/TISSUE LOSS, OR EXTENDED OPERATING ROOM TIME. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 12MM ST W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1