BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELESS VP 11MM ST W/ FIXATION

    MDR report key: 2182171 · Received July 28, 2011

    Report

    Report Number
    1219930-2011-00428
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 2, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE TROCAR BROKE DURING INSERTING. THE SURGEON HAD TO LOOK FOR THE PART THAT BROKE IN THE PT. IT TOOK THE SURGEON HALF AN HOUR TO FIND IT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADELESS VP 11MM ST W/ FIXATION DISPOSABLE SURGICAL ACCESS DEVICE GCJ UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1