BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRPT PLUS RPF 10MM -15MM TRC W/100MM SLV

    MDR report key: 1250830 · Received November 25, 2008

    Report

    Report Number
    2647580-2008-00656
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 29, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: OOPHORECTOMY. ACCORDING TO THE REPORTER: IT WAS NOT POSSIBLE TO DEACTIVATE THE SAFETY SHIELD. THIS DEVICE WAS NOT UTILIZED DURING THE PROCEDURE. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRPT PLUS RPF 10MM -15MM TRC W/100MM SLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE-USS P7K0179

    Patients

    Seq Age Sex Outcome Treatment
    1