BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADELESS VP 12MM ST W/ FIXATION

    MDR report key: 2221614 · Received August 19, 2011

    Report

    Report Number
    1219930-2011-00713
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC APPENDECTOMY. ACCORDING TO THE REPORTER: WHILE PLACING THE TROCAR, THE SURGEON STATED THERE WAS A LOT OF SCAR TISSUE IN THE FASCIA, THE TIP OF THE TROCAR BROKE INTO THE CAVITY. X-RAYS WERE NOT TAKEN, SURGEON TRIED TO FIND THE PIECE VISUALLY AND COULD NOT LOCATE IT. THE PIECE STILL REMAINS INSIDE THE PT CAVITY. A NEW TROCAR WAS OPENED TO COMPLETE THE PROCEDURE. NO BLEEDING WAS REPORTED. THERE WAS NO DELAY IN OPERATIVE TIME. NO TISSUE DAMAGE OCCURRED.

    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 N1E0127L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other