BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOGATOR

    MDR report key: 4972514 · Received July 22, 2015

    Report

    Report Number
    4972514
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MEDIVATORS INC.
    Product Code
    OCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    SCOPE IRRIGATOR PEDAL MALFUNCTIONED AND FLATTENED AND WAS UNUSABLE DURING PROCEDURE. PEDAL SHOULD BE INFLATED TO WORK PROPERLY. EQUIPMENT HAD TO BE MANIPULATED MULTIPLE TIMES DURING PROCEDURE TO GET IT TO WORK PROPERLY. CLINICAL ENGINEERING EVALUATED EQUIPMENT FAILURE AND DETERMINED THAT THE PEDAL WAS WORN OUT. A NEW PEDAL ORDERED.====================== MANUFACTURER RESPONSE FOR ENDOSCOPE IRRIGATOR PEDAL, SCOPE IRRIGATOR PEDAL (PER SITE REPORTER)======================CONTACTED CUSTOMER SERVICE AT MEDIVATORS. THE CUSTOMER SERVICE STAFF INDICATED THEY DO NOT NEED THE MALFUNCTIONING EQUIPMENT RETURNED. THIS IS AN ISSUE WHICH IS REMEDIED BY PURCHASING NEW PEDALS. AGE OF EQUIPMENT IS UNKNOWN. FEEL IT WAS DUE TO BE REPLACED ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474194 ENDOGATOR ENDOSCOPE AND/OR ACCESSORIES OCX MEDIVATORS INC. EGP-100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES