BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADELSS VP 11MM ST W/FIXATION

    MDR report key: 3070991 · Received April 1, 2013

    Report

    Report Number
    9612501-2013-00024
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K081169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ACCORDING TO THE REPORTER: THE BLUE TIP OF THE TROCAR THAT COVERS THE BLADE FELL OFF INTO THE PT'S ABDOMEN. THE BLUE TIP WAS RETRIEVED. THE CASE WAS CONTINUED WITH NO BLOOD LOSS, NO TISSUE DAMAGE OR DELAY IN OPERATING ROOM TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133365 BLADELSS VP 11MM ST W/FIXATION DISPOSABLE SURGICLA ACCESS DEVICE GCJ COVIDIEN J2G0064X

    Patients

    Seq Age Sex Outcome Treatment
    1