BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPT BL VP V2 5MM STD W/FX

    MDR report key: 3100039 · Received April 29, 2013

    Report

    Report Number
    1219930-2013-00293
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GCJ
    PMA / PMN Number
    K112349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; THE BLUE SEAL CAME OFF DURING THE PROCEDURE BUT DID NOT FALL INTO THE PT CAVITY NOR WAS ANY PT INJURY REPORTED. THE SURGEON USED ANOTHER ONB5STF TO CONTINUE THE CASE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184210 OPT BL VP V2 5MM STD W/FX DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SUR N2M0243X

    Patients

    Seq Age Sex Outcome Treatment
    1