BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN MEDSYSTEMS INC

    MDR report key: 245512 · Received October 20, 1999

    Report

    Report Number
    MW1017358
    Event Type
    Malfunction
    Date Received
    October 20, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 14, 1999
    Manufacturer
    ORIGIN MEDSYSTEMS INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BALLOON TIP ON TROCAR BURST WHILE IN PT'S ABDOMEN. PHYSICIAN CHECKED FOR PIECES OF BALLOON. NO PIECES FOUND. STATES ALL OF THE BALLOON APPEARED TO REMAIN ON THE TROCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN MEDSYSTEMS INC SURGICAL TROCAR AND SYRINGE GCJ ORIGIN MEDSYSTEMS INC. * 1204992

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other