BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1210035 · Received October 21, 2008

    Report

    Report Number
    2647580-2008-00602
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 10, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GCJ
    PMA / PMN Number
    K954108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 10/21/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: OOPHOROCYSTECTOMY. ACCORDING TO THE REPORTER: AFTER USING A MORCELLATOR THROUGH THE TROCAR, THE TROCAR DISLODGED FROM THE PT BODY. UPON REINSERTING IT INTO THE PT CAVITY, CONFIRMED A PART OF TROCAR WAS BROKEN. NOTHING FELL INTO THE CAVITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER. NO TISSUE DAMAGE. NO BLEEDING. EXTENDED OR TIME: UNK. 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 VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV DISPOSABLE SURGICAL ACCESS DEVICE GCJ PONCE-USS P7D0427

    Patients

    Seq Age Sex Outcome Treatment
    1