BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPORT LAPAROSCOPIC SYSTEM

    MDR report key: 3021318 · Received March 18, 2013

    Report

    Report Number
    3021318
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 18, 2013
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    INSETTER TORE WHEN SURGEON WENT TO INSERT DEVICE. A NEW GELPORT WAS ADDED TO THE SURGICAL FIELD AND 2ND DEVICE INSERTED WITHOUT INCIDENT. THE PROCEDURE CONTINUED AS PLANNED. NO HARM TO THE PATIENT PER SURGEON REPORT AND JUST A 2 MINUTE OR DELAY AWAITING A 2ND GELPORT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC COLON RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111817 GELPORT LAPAROSCOPIC SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. * 1186498

    Patients

    Seq Age Sex Outcome Treatment
    1 *