BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 5004154 · Received August 14, 2015

    Report

    Report Number
    9611174-2015-00006
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    KEYMED LTD HAVE REQUESTED THE RETURN OF THE SUBJECT DEVICE FROM (B)(6), SO THAT A FULL INVESTIGATION CAN TAKE PLACE TO ESTABLISH THE ROOT CAUSE OF THIS MALFUNCTION. AWAITING RETURN OF SUBJECT DEVICE.

    Additional Manufacturer Narrative · 1

    KEYMED LTD HAVE RECEIVED THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN EVALUATED. THE EVALUATION DETERMINED THAT ONE SOCKET OUTLET ON THE CENTRAL STRIP WAS SEVERELY ERODED AROUND THE LEFT HAND POWER CONTACT DUE TO EXTREME HEAT. INTERNALLY THERE WAS SOME DISTORTION OF THE MOULDING WHERE THE CONTACT IS SECURED, BUT NOT TO THE SAME EXTENT AS EXTERNALLY. THE EQUIPMENT LEAD PLUG HAS NOT BEEN FULLY ENGAGED WITH THE SOCKET, SO THAT ITS LEFT HAND PIN WAS ONLY TOUCHING THE SOCKET CONTACT AT ITS TIP RATHER THAN BEING GRIPPED ON BOTH SIDES AS IT WOULD NORMALLY BE WHEN THE PLUG IS FULLY ENGAGED. THE SINGLE POINT OF CONTACT WILL PRODUCE CONSIDERABLE HEAT WHEN CURRENT IS FLOWING. THE IFU ALREADY CONTAINS CAUTIONS TO ENSURE THAT CONNECTORS ARE FULLY ENGAGED WHEN THE SYSTEM IS CONFIGURED AND TO CHECK THEM DURING ROUTINE MAINTENANCE.

    Description of Event or Problem · 1

    THE OLYMPUS WM-NP2 MOBILE WORKSTATION IS INTENDED FOR USE IN MEDICAL FACILITIES UNDER THE DIRECTION OF A TRAINED PHYSICIAN, AND HAS BEEN DESIGNED TO BE USED WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE GI ENDOSCOPY, ENDOSCOPIC ULTRASOUND, RESPIRATORY AND SURGICAL ENDOSCOPIC PROCEDURES. THE SUBJECT DEVICE, A SEPARATION TRANSFORMER (B)(4), IS LOCATED ON THE UNDERSIDE OF THE BASE SHELF. THE SEPARATION TRANSFORMER CONNECTS TO THE MAINS POWER SUPPLY AND HAS A BANK OF OUTPUT SOCKETS WHICH ALLOWS FOR THE ELECTRICAL CONNECTION OF OLYMPUS MEDICAL DEVICES WHICH ARE SITUATED ON THE WORKSTATION. KEYMED (MEDICAL &INDUSTRIAL EQUIPMENT) LTD, HAS BEEN MADE AWARE OF AN EVENT IN (B)(6) WHERE DURING THE PREPARATION FOR USE, A SNAPPING NOISE OCCURRED AS THE FACILITY STAFF POWERED ON A (B)(4) LIGHT SOURCE WHICH WAS INSTALLED ON THE WORKSATATION. FACILITY STAFF CHECKED THE (B)(4) SEPARATION TRANSFORMER AND FOUND THAT THE OUTPUT SOCKET OF THE TRANSFORMER WHICH CONNECTED TO THE (B)(4) LIGHT SOURCE HAD MELTED. THE HEALTH FACILITY USED ANOTHER WORKSTATION TO PERFORM THE PROCEDURE. THERE IS NO REPORT OF INJURY TO PATIENT OR USER AND THEREFORE THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540454 OLYMPUS MAJ-1646 SEPARATION TRANSFORMER FOR THE WM-NP2 WORKSTATION FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD MAJ-1646

    Patients

    Seq Age Sex Outcome Treatment
    1