BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL TROCAR

    MDR report key: 17824 · Received November 17, 1994

    Report

    Report Number
    MW1004056
    Event Type
    Injury
    Date Received
    November 17, 1994
    Date of Event
    November 10, 1994
    Report Date
    November 15, 1994
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPROSCOPIC LYMPH NODE DISSECTION, THE BALLOON OF A SURGICAL TROCAR (11 MM) BROKE INSIDE THE PT, LEAVING BEHIND A PIECE OF THE BALLOON. THIS REQUIRED INTERVENTION TO REMOVE THE REMAINING BALLOON PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL TROCAR SINGLE USE SURGICAL TROCAR WITH BALLOON GCJ ORIGIN MEDSYSTEMS, INC. 1270031194

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention