BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV

    MDR report key: 1160775 · Received September 8, 2008

    Report

    Report Number
    2647580-2008-00524
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 21, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORT: THE DOCTOR WAS INSERTING THE VERSASTEP FOR TROCAR INSERTION. WHILE WATCHING THE SCREEN IT WAS NOTICED A PIECE OF THE VERSASTEP SLEEVE WAS TORN LOOSE AND LYING FREE INSIDE THE PATIENT'S ABDOMEN. THE DOCTOR THEN USED A GRASPING FORCEPS TO REMOVE THE PLASTIC FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P8E0598

    Patients

    Seq Age Sex Outcome Treatment
    1