BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 3981211 · Received July 23, 2014

    Report

    Report Number
    8010047-2014-00403
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 23, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION; THEREFORE, OMSC COULD NOT EVALUATE THE REFERENCED DEVICE. ALSO NO FAILURE OF THE DEVICE WAS REPORTED. WHEN THE ADHESION IS LOCATED NEAR THE SURGICAL SITE OR THE ELECTRIC DISCHARGE OCCURS AT THE ELECTRODE, IT IS GENERALLY KNOWN THAT THE PATIENT'S MUSCLE MAY BE STIMULATED. ALSO, DURING THE TRANSCERVICAL RESECTION, IT IS GENERALLY KNOWN THAT THE PATIENT'S LEG MAY MOVE BY OBTURATOR-NERVE-REFLEX. FURTHERMORE, IT IS UNKNOWN WHETHER THE PATIENT HAS ACTUALLY SUFFERED THE BURN OR NOT; HOWEVER, DURING THE ELECTROSURGICAL PROCEDURE, IT IS GENERALLY KNOWN THAT THE BURN MAY OCCUR BY THE USER HANDLING. THE UES-40 INSTRUCTION MANUAL STATES THE NOTICE FOR THE HANDLING OF THE DEVICE. ALSO, OMSC CHECKED THE MANUFACTURER HISTORY OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE ENDOMETRIAL POLYP TRANSCERVICAL RESECTION WITH LOCAL ANESTHESIA THE PATIENT'S BOTH LEGS JUMPED TWICE AS STIMULATED. AFTER THE PROCEDURE, BECAUSE THE PATIENT FELT A PAIN IN THE LEGS, THE FACILITY PERFORMED THE COLOR DOPPLER ULTRASONOGRAPHY OF THE LEG VEIN AND THE ELECTROMYOGRAPHY (EMG); HOWEVER, THE PATIENT DID NOT HAVE ANY ABNORMALITY. THE PHYSICIAN THOUGHT THAT THE PATIENT HAD POSSIBILITIES OF THE BURN, THE PHYSICIAN PRESCRIBED A WESTERN-STYLE MEDICINE AND A CHINESE-STYLE MEDICINE FOR THE PATIENT. AFTER ONE MONTH, BECAUSE THE PATIENT STILL COMPLAINED OF THE LEG PAIN, THE FACILITY PERFORMED THE EMG AGAIN. HOWEVER, THE PATIENT DID NOT HAVE ANY ABNORMALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432440 OLYMPUS SURGMASTER ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR