BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAT PROBE

    MDR report key: 4073633 · Received August 21, 2014

    Report

    Report Number
    8010047-2014-00453
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICES HAVE NOT BEEN RETURNED TO OMSC FOR INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. (B)(4).

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORP. (OMSC) WAS INFORMED THAT THE WIRE OF THE DEVICE CONNECTOR WAS EXPOSED WHEN THEY ATTEMPTED TO REMOVE THE PROBE FROM HEATER PROBE UNIT. THIS EVENT OCCURRED WITH 3 DIFFERENT CDS. THERE WAS NO PT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505058 HEAT PROBE HEAT PROBE KNS OLYMPUS MEDICAL SYSTEMS CORPORATION CD-120U UNK

    Patients

    Seq Age Sex Outcome Treatment
    1