BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT PLUS

    MDR report key: 3030045 · Received March 27, 2013

    Report

    Report Number
    3030045
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    COVIDIEN FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTH CARE
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TROCAR SIDE PORT BROKE OFF WHILE IN USE. NO PIECES FELL INTO PATIENT. BROKEN PART RETRIEVED AND SAVED WITH TROCAR. STAFF WAS ABLE TO CLOSE VALVE TO "OFF" POSITION AND PROCEED WITH PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125910 VERSAPORT PLUS LAPAROSCOPE GCJ COVIDIEN FORMERLY VALLEY LAB, A DIVISION OF TYCO HEALTH CARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR