BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSTEP REP STD RAD EXP SLV W5-12M VSEALPL

    MDR report key: 1864402 · Received October 4, 2010

    Report

    Report Number
    2647580-2010-00814
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 5, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPARO OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: DURING THE CASE, A BLUE PIECE OF THE DEVICE FELL INTO PT CAVITY. IT MIGHT BE A PIECE OF 5 MM OUTER CYLINDER. THE PIECE COULD BE RETRIEVED. NO BLEEDING. NO TISSUE DAMAGED. NOT EXTENDED MORE THAN 30 MINUTES. NO PT INJURY WAS REPORTED. NO PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VSTEP REP STD RAD EXP SLV W5-12M VSEALPL DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1