BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP 5MM SGLUSE DILT/CANN W/EXPSLV

    MDR report key: 1081881 · Received July 21, 2008

    Report

    Report Number
    2647580-2008-00406
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP APPENDECTOMY. ACCORDING TO THE RPTR: WHILE INSERTING A DILATOR INTO THE EXPANDABLE SLEEVE, THE TIP OF INSTRUMENT BROKE OFF AND THE BROKEN PIECE FELL INTO THE CAVITY. THE SURGEON REMOVED THE INSTRUMENT AND RETRIEVED THE BROKEN PIECE FROM THE CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED. PT STATUS: OK. NO FURTHER PT INFO AVAILABLE.

    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 P8B0805

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR