BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL

    MDR report key: 1111992 · Received August 12, 2008

    Report

    Report Number
    2647580-2008-00462
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: DURING SURGERY THE SEAL BROKE AND A BLUE BROKEN PIECE FELL INTO THE CAVITY. IT WAS IMMEDIATELY RETRIEVED. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TISSUE DAMAGE AND NO EXCESSIVE BLEEDING. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. NO PT INJURY WAS REPORTED. NO FURTHER PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS P7H1064

    Patients

    Seq Age Sex Outcome Treatment
    1