BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS

    MDR report key: 2112937 · Received May 25, 2011

    Report

    Report Number
    2647580-2011-00364
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    May 10, 2011
    Manufacturer
    USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE PLASTIC AT TIP OF TROCAR SHAVED OFF WHEN INSERTED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS. THERE WAS NO UNANTICIPATED TISSUE LOSS. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +IO- 5MM GUARD TROCR (KIT2 SLV) 65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO, INC. P9A1067

    Patients

    Seq Age Sex Outcome Treatment
    1