BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 3912079 · Received May 12, 2014

    Report

    Report Number
    9611174-2014-00003
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE WM-260 MOBILE WORKSTATION IS INTENDED FOR USE IN MEDICAL FACILITIES UNDER THE DIRECTION OF A TRAINED PHYSICIAN, AND HAD BEEN DESIGNED TO BE USED WITH THE OLYMPUS LUCERA RANGE IF EQUIPMENT AS PART OF AN OLYMPUS GI ENDOSCOPY SYSTEM. DURING THE PREPARATION FOR USE CHECK UNDERTAKEN PRIOR TO THE START OF THE PROCEDURE (THERAPEUTIC PROCEDURE - ENDOSCOPIC ULTRASOUND-GUIDED TRANSMURAL CYST DRAINAGE), THE OPERATOR NOTICE A BURNING SMELL FROM AROUND THE DEVICE WHICH IS THE SUBJECT OF THIS REPORT AND ALSO A SLIGHT SPARK AND SMOKE WERE GENERATED FROM THE REAR PANEL OF THE WM-260. THE START OF THE PROCEDURE WAS DELAYED AS THE FACILITY CHANGED TO ANOTHER SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY AND THEREFORE THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283551 OLYMPUS WM-260 MOBILE WORKSTATION FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. WM-260

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR (B)(4) (IMAGE FILING)| OEV261H| (B)(4) DVD RECORDER| UP-897MD| CV-260H| EU-ME1