BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE VERSASTEP PLUS

    MDR report key: 1221426 · Received October 30, 2008

    Report

    Report Number
    1221426
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 30, 2008
    Manufacturer
    COVIDIEN UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A LAPAROSCOPIC NEPHRECTOMY. AS THE DOCTOR WAS INSERTING AND REMOVING INSTRUMENTS FROM THE VERSASTEP PORT, HE SAW SMALL BITS OF BLUE MATERIAL FALL OFF OF THE PORT AND INTO THE PATIENT. THE DOCTOR AND THE SCRUB TECH HAD SEEN THIS ISSUE PREVIOUSLY ON ANOTHER PATIENT AND QUICKLY ATTEMPTED TO CLEAR THE DEBRIS. THE PATIENT DOES NOT APPEAR TO BE INJURED AS A RESULT OF THE BLUE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE VERSASTEP PLUS TROCAR, BLADELESS GCJ COVIDIEN UNITED STATES SURGICAL CORPORATION * P8G0825

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR