BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 3902200 · Received June 23, 2014

    Report

    Report Number
    8010047-2014-00342
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE FACILITY CONTINUES TO USE THE DEVICE. ALSO OMSC WAS NOT INFORMED THAT THE SUBJECT DEVICE HAD ANY FAILURE. ACCORDING TO THE LITERATURE, IT IS KNOWN THAT GAS BUBBLES MAY OCCUR DURING THE PROCEDURE OF TURIS AND A SMALL EXPLOSION MAY OCCUR INFREQUENTLY BECAUSE OF CHEMICAL REACTION OF THE GAS BUBBLES. THE REPORTED PHENOMENON IS THOUGHT OF AS COMMON COMPLICATION OF TURIS. THE UES-40S INSTRUCTION MANUAL STATES THE NOTICE FOR THE HANDLING OF THE DEVICE. ALSO, OMSC CHECKED THE MANUFACTURE 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 TURIS-BT PROCEDURE TO RESECT THE ECCHYMOMA IN THE PATIENT'S BLADDER, THE PHYSICIAN HAD HEARD THE POPPING SOUND AND NOTICED THE BLEEDING FROM THE PATIENT'S BLADDER. THE PHYSICIAN HAD BEEN PERFORMING THE PROCEDURE WITH THE USE OF WRONG ELECTRODE (NOT FOR TURIS). HOWEVER, WHEN THE PHYSICIAN HAD TRIED TO STOP THE BLEEDING., HE HAD FOUND THAT THE ELECTRODE HAD BEEN WRONG. HE HAD CHANGED IT TO CORRECT ONE. THE PHYSICIAN HAD STOPPED THE BLEEDING AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365774 OLYMPUS SURGMASTER ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40S N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other