BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 3854880 · Received May 26, 2014

    Report

    Report Number
    8010047-2014-00258
    Event Type
    Injury
    Date Received
    May 26, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 28, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. NO IRREGULARITY OF THE SUBJECT DEVICE WAS OBSERVED. IT WAS WITHOUT THE ERROR LOG RELATED TO THIS EVENT. THERE IS THE POSSIBILITY THAT THE PT'S PLATE WAS NOT SUITABLE FOR THIS PROCEDURE, NOR THE CONTACT OF IT TO THE PT WAS NOT SUITABLE. THE UES-40 INSTRUCTION MANUAL ALREADY STATES; THE CONNECTABLE PT PLATES ARE LISTED BELOW: OLYMPUS MAJ-897, 3M 7179, 9165. THESE HAVE BEEN TESTED AND FOUND TO BE SAFE. WHEN YOU INTEND TO USE THE UNIT IN A CONFIGURATION THAT IS NOT LISTED IN THE "SYSTEM CHART" IN THE APPENDIX, CONFIRM THAT THE UNIT FUNCTIONS SAFELY IN THAT SYSTEM CONFIGURATION BEFORE PROCEEDING. NOTE THAT WITH CERTAIN PT PLATES, THE CQM MONITOR MAY MALFUNCTION EVEN WHEN THE POWER SUPPLY IS NORMAL. IMPROPER CONNECTION BETWEEN THE PT PLATE AND THE PT'S SKIN SURFACE MAY CAUSE BURNS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A HYSTEROSCOPIC PROCEDURE, THE PT RECEIVED A SECOND DEGREE TO THIRD DEGREE BURN ON THE LEFT ON THE CORRESPONDENT AREA OF THE PT PLATE. THE DEVICE DID NOT MAKE ANY KIND OF ERROR MESSAGE DURING THE PROCEDURE. THE HOSPITAL WAS NOT USING THE OLYMPUS SUGGESTED PLATES, BUT THE "SKIN TACT" PLATE WHICH WAS NOT INCLUDED IN THE INSTRUCTION MANUAL. THE DOCTOR WROTE THAT THE PLATE WAS CORRECTLY APPLIED TO THE PT'S BODY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309992 OLYMPUS SURGMASTER ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR