BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2823573 · Received October 8, 2012

    Report

    Report Number
    2647580-2012-00642
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: DURING THE ENDOSCOPIC SURGERY, THE TROCAR SPIKE HAD A BARB AND CUT THE TIP OF THE TROCAR WHICH LEAD TO ORANGE SCRAPS. A NEW DEVICE WAS REPLACED. NOTHING FELL INTO THE PT CAVITY, THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC, THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINS, THERE WAS NO UNANTICIPATED ISSUE LOSS.

    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 COVIDIEN, FORMERLY USSC PUERTO RICO P1G0611

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly