BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN STEP DEVICE

    MDR report key: 3222105 · Received July 1, 2013

    Report

    Report Number
    1219930-2013-00496
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE: JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPY.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC. ACCORDING TO THE REPORTER: THERE WAS ONE COMPLICATION ASSOCIATED WITH THE STEP SYSTEM: INSERTION OF THE VERESS NEEDLE CAUSED AN ABDOMINAL VESSEL INJURY, WHICH WAS REPAIRED INTRAOPERATIVELY WITH A SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297859 UNKNOWN STEP DEVICE DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1