BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EGD SCOPE

    MDR report key: 6507136 · Received April 18, 2017

    Report

    Report Number
    MW5069198
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    March 28, 2017
    Report Date
    April 18, 2017
    Manufacturer
    OLYMPUS
    Product Code
    NWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EGD SCOPE IN USE. FIFTH PATIENT THIS PARTICULAR SCOPE WAS USED ON IN 3 MONTH TIME FRAME. FIRST USE WAS ON (B)(6) 2017. DURING THE USE ON (B)(6) 2017, LOSS OF SUCTION OCCURRED. BRUSH USED TO BRUSH SUCTION SIDE AND RESOLUTION CLIP FELL OUT OF SCOPE. SCOPE HAD BEEN PROCESSED AND CLEANED MORE THAN 10 TIMES DURING THIS TIME FRAME, USING ALDAHOL. TISSUE SENT FOR DNA TESTING ALONG WITH 5TH PATIENT'S BLOOD. DNA DID NOT MATCH AS TISSUE BELONGED TO MALE AND BLOOD BELONGED TO FEMALE. ONLY ONE MALE PATIENT HAD BEEN SCOPED USING THIS PARTICULAR EGD SCOPE, WITH 3 FEMALE PATIENTS TO FOLLOW HIM. EGD SCOPE IMMEDIATELY TAKEN OUT OF SERVICE ON DATE OF EVENT AND SENT TO MANUFACTURER (OLYMPUS). STATE HEALTH DEPARTMENT NOTIFIED WITH DETERMINATION CHANCES OF EXPOSURE TO INFECTIOUS DISEASE WAS VERY MINIMAL. LETTERS TO BE ISSUED TO THREE FEMALE PATIENTS NOTIFYING THEM OF THE INCIDENT. MANUFACTURER OF RESOLUTION CLIPS (BOSTON SCIENTIFIC) ALSO NOTIFIED OF INCIDENT. ONE SAME DATE, HAD HYSTEROSCOPY AND OPERATIVE LAPAROSCOPY DONE DUE TO ENDOMETRIAL POLYPECTOMY WITH UTERINE PERFORATION. HYSTEROSCOPY WAS PLANNED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280959 OLYMPUS EGD SCOPE ENDOSCOPE AND ACCESSORIES NWB OLYMPUS GIF-Q180

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention