BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO+ 5.5MM/65MM GUARDED TROCR/CANN W/GAS

    MDR report key: 3973076 · Received June 6, 2014

    Report

    Report Number
    2647580-2014-00421
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO REPORTER: PRODUCT WAS OPENED FOR USE AND WHEN DOCTOR ATTEMPTED TO INSERT, THE TROCAR BROKE. A NEW ONE WAS RETRIEVED FROM THE SET UP AREA AND USED TO COMPLETE PROCEDURE NO ITEM FELL INTO THE SURGICAL CAVITY. THERE WAS NO UNANTICIPATED TISSUE LOSS AND NO TISSUE DAMAGE. THERE WAS NO BLOOD LOSS OF 500CC OR MORE. SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331050 IO+ 5.5MM/65MM GUARDED TROCR/CANN W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC P1M0055

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR