BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 6126941 · Received November 24, 2016

    Report

    Report Number
    9611174-2016-00006
    Event Type
    Malfunction
    Date Received
    November 24, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 2, 2016
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF HIGH QUALITY IMAGES SUPPLIED BY OLYMPUS (B)(4) CONFIRMS A BURNED AND BROKEN "LIVE" CONNECTION PIN IN THE MAINS CONNECTOR. FROM THE IMAGE PROVIDED THE UPPER MOST PORTION OF THE CONTACT PIN CAN CLEARLY BE SEEN TO HAVE ABLATED FROM THE ARCING PRESENT AFTER THE CONTACT HAD BROKEN. DEPOSITS AND HEAT DAMAGE FROM THE ARCING OF THIS PIN CAN ALSO CLEARLY BE SEEN ON THE IMAGE OF THE WALL POWER OUTLET SOCKET. THE CAUSE OF THE EVENT IS MECHANICAL STRESSING OF THE PINS OF THE MAINS PLUG. THE PRIMARY CAUSES OF MECHANICAL STRESSING ARE "MOVING THE WORKSTATION WHILST PLUGGED IN", "RUNNING OVER THE PLUG WITH THE WORKSTATION" AND "CLINICAL STAFF TREADING ON THE MAINS LEAD OR TRIPPING ON THE MAINS LEAD". A CLEAR INSTRUCTION TO THE CUSTOMER EXISTS IN THE IFU REQUIRING THE CUSTOMER TO REGULARLY INSPECT THE MAINS PLUG AND LEAD AND TO REPLACE THE MAINS LEAD AT THE FIRST SIGN OF DAMAGE TO THE CONNECTOR OR THE LEAD. CONSEQUENTLY THE ROOT CAUSE OF THIS FAILURE IS THE USER DISREGARDING THIS INSTRUCTION TO THE CUSTOMER IN THE IFU. IF THIS INSTRUCTION IS DISREGARDED THIS CAN LEAD TO THE FAILURE OF THE MAINS CONNECTOR DESCRIBED IN THIS EVENT.

    Description of Event or Problem · 1

    OLYMPUS MOBILE WORKSTATIONS ARE INTENDED FOR USE IN MEDICAL FACILITIES UNDER THE DIRECTION OF A TRAINED PHYSICIAN AND ARE DESIGNED TO BE USED WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE GI ENDOSCOPY, ENDOSCOPIC ULTRASOUND, RESPIRATORY AND SURGICAL ENDOSCOPE PROCEDURES. KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD HAVE BEEN MADE AWARE OF AN EVENT WHEREBY DURING THE PREPARATION FOR USE IN AN UNSPECIFIED PROCEDURE, THE USER OF THE HEALTHCARE FACILITY INSERTED THE POWER PLUG INTO THE SUPPLY SOCKET, A STRANGE ODOUR WAS NOTICED. THE USER REMOVED THE POWER PLUG FROM THE SUPPLY SOCKET AND INSERTED IT INTO ANOTHER (SECOND) POWER SUPPLY SOCKET. SMOKE OCCURRED BETWEEN THE POWER PLUG AND THE SECOND POWER SUPPLY SOCKET. THE USER REMOVED THE POWER PLUG FROM THE SECOND POWER SUPPLY SOCKET AND THE PLUG BROKE. IMAGES SUPPLIED FROM OLYMPUS JAPAN SHOW THE LIVE PIN OF THE PLUG IS MISSING AND THERE IS SCORCHING. THERE IS NO REPORT OF INJURY TO PATIENT OR USER AND THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777815 OLYMPUS WM-NP1 MOBILE WORKSTATION FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD WM-NP1

    Patients

    Seq Age Sex Outcome Treatment
    1