BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV

    MDR report key: 3982502 · Received June 23, 2014

    Report

    Report Number
    9612501-2014-00190
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: 3 OF THE 5MM TROCARS WERE INSERTED FOR THE SURGERY. WHEN SUCTION IRRIGATION TIPS WERE INSERTED THROUGH THE CANNULA (STRYKER LAPAROSCOPIC TIP), THEY WERE DIFFICULT TO REMOVE. FOR ONE OF THE CANNULAS, THE TIP COULD NOT BE REMOVED FROM THE CANNULA. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO EXTENSION OF INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367154 VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN J4C0059X

    Patients

    Seq Age Sex Outcome Treatment
    1