BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 590889 · Received June 2, 2004

    Report

    Report Number
    2647580-2004-00131
    Event Type
    Malfunction
    Date Received
    June 2, 2004
    Date of Event
    May 25, 2004
    Report Date
    May 27, 2004
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SEAL ON THE CONVERTER OF THE TROCAR BECAME DISENGAGED AND FELL INTO THE PT'S BODY CAVITY AND RETRIEVED. PROCEDURE: LGB. PT STATUS: NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV DISPOSABLE LAPROSCOPIC ACCESS DEVICE GCJ PONCE - USS NA P4C875

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR