BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNER DYNE, INC.

    MDR report key: 243392 · Received September 29, 1999

    Report

    Report Number
    243392
    Event Type
    Injury
    Date Received
    September 29, 1999
    Date of Event
    September 22, 1999
    Report Date
    September 27, 1999
    Manufacturer
    INNER DYNE INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSOCPIC SURGERY, IT WAS NOTED THAT THE TROCAR WAS MISSING A PIECE OF THE LOWER PORTION OF THE TROCAR. A PIECE OF APPROXIMATELY 2MM X 4MM WAS DEEMED TO BE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNER DYNE, INC. 12MM REPOSABLE STEP GEA INNER DYNE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention