BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT 12MM CANN/DILATOR W/RAD EXPAND SLV

    MDR report key: 3060484 · Received March 26, 2013

    Report

    Report Number
    2647580-2013-00197
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K961430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPY. ACCORDING TO THE REPORTER: THE DIAPHRAGM RIPPED APART AND PARTICLES LODGED IN THE PATIENT. THE SURGEON REMOVED THE PARTICLES AND USED A NEW PART. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. IT IS UNK IF REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122912 SHORT 12MM CANN/DILATOR W/RAD EXPAND SLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1