BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 328259 · Received April 12, 2001

    Report

    Report Number
    328259
    Event Type
    Injury
    Date Received
    April 12, 2001
    Date of Event
    March 14, 2001
    Report Date
    April 4, 2001
    Manufacturer
    ELMED INC
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DIAGNOSTIC LAPAROSCOPY, THE SURGEON WAS PREPARING TO USE ENDOSHEARS TO REMOVE CYST. THE SURGEON NOTICED SMOKE. INSPECTION OF THE PELVIS REVEALED A TERMAL INJURY TO THE COLON. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. A GENERAL SURGEON WAS CALLED TO REPAIR THE COLON AND THE CYSTECTOMY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16790 UNK MONOPOLAR LAPAROSCOPIC CORD HET ELMED INC 20917 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention