BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 275853 · Received May 1, 2000

    Report

    Report Number
    275853
    Event Type
    Injury
    Date Received
    May 1, 2000
    Date of Event
    April 27, 2000
    Report Date
    April 28, 2000
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ORIGIN BLUNT TIP SURGICAL TROCAR: BALLOON BURST INSIDE OF PT ON REMOVAL. BITS & PIECES OF THE BALLOON HAD TO BE MANUALLY REMOVED EXTENDING THE SURGICAL TIME REQUIRED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN SURGICAL TROCAR AND SYRINGE BLUNT GCJ ORIGIN MEDSYSTEMS, INC. OMS-T10BT 1112951

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention