BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS ENDOSONIC ULTRASONCI CLEANER

    MDR report key: 3853676 · Received April 4, 2014

    Report

    Report Number
    9611174-2014-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT HAS BEEN DISPOSED OF BY THE HEALTHCARE FACILITY. THE DEVICE WAS RETURNED TO THE OLYMPUS FACILITY AT (B)(4), WHERE AN INITIAL INVESTIGATION TOOK PLACE. THE DEVICE WAS THEN RETURNED TO THE HEALTHCARE FACILITY, WHO HAVE SUBSEQUENTLY DISPOSED OF THE DEVICE WHICH IS THE SUBJECT OF THIS REPORT AND PURCHASED A NEW ENDOSONIC CLEANER. PHOTOGRAPHS TAKEN AT THE TIME OF THE INITIAL INVESTIGATION IN (B)(4) HAVE BEEN FORWARDED TO KEYMED AND SHOW FAILED TRANSDUCER WIRES, SCORCH MARKS AND EVIDENCE OF UNIDENTIFIED CONTAMINATION.

    Description of Event or Problem · 1

    THE OLYMPUS ENDOSONIC ULTRASONIC CLEANER IS A PRODUCT WHICH ENABLES THE CLEANING OF OLYMPUS ENDOSCOPIC ACCESSORIES AND ANCILLARY EQUIPMENT BY QUALIFIED TECHNICAL OR NURSING STAFF IN THE CLEANING ROOM OF A MEDICAL FACILITY WHERE FLEXIBLE ENDOSCOPIC ACCESSORIES ARE REPROCESSED. THE ITEMS TO BE CLEANED ARE PLACED IN A PURPOSE-DESIGNED BASKET AND THEN IMMERSED IN THE ENDOSONIC TANK, WHICH IS FILLED TO THE APPROPRIATE LEVEL WITH ULTRASONIC CLEANING SOLUTION. THE FLUID IS AGITATED ULTRASONICALLY TO REMOVE DEBRIS AND CONTAMINATION THE ITEMS. FOLLOWING CLEANING, THE ITEMS MUST BE REPROCESSED IN LINE WITH THEIR INSTRUCTIONS FOR USE. KEYMED HAS BEEN MADE AWARE OF AN EVENT WHERE 17 MINUTES INTO THE CLEANING CYCLE OF THE ENDOSONIC CLEANER, THE USER NOTICED A BURNING SMELL. THERE WAS NO REPORT OF USER INJURY AN THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205287 OLYMPUS ENDOSONIC ULTRASONCI CLEANER ENDOSONIC CLEANER FLG KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. ENDOSONIC CLEANER SEE SERIAL NUMBER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA