BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP REPO SHRT PWSHIELD 12MM RAD

    MDR report key: 1081883 · Received July 21, 2008

    Report

    Report Number
    2647580-2008-00401
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 23, 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: OOPHORECTOMY. ACCORDING THE REPORTER: WHILE INSERTING THE DEVICE INTO THE SLEEVE, THE TIP OF INSTRUMENT BROKE. THE BROKEN PIECES FELL INTO THE PT'S CAVITY, HOWEVER, THE PIECES WERE RETRIEVED. THIS WAS USED MORE THAN 160 TIMES, WITH ABOUT 282 VS HOUSINGS. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED. NO TISSUE DAMAGE. NO BLEEDING. 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 REPO SHRT PWSHIELD 12MM RAD DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE - USS

    Patients

    Seq Age Sex Outcome Treatment
    1