BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    MDR report key: 3289551 · Received August 9, 2013

    Report

    Report Number
    8010047-2013-00324
    Event Type
    Other
    Date Received
    August 9, 2013
    Report Date
    July 19, 2013
    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 SUBJECT DEVICE IS NOT REPORTED TO OMSC, SO THERE IS NO INFO WHETHER IT HAS ANY FAILURE OR NOT OMSC WAS NOT INFORMED THAT THE SUBJECT DEVICE HAS ANY FAILURE. ACCORDING TO THE LITERATURE, IT IS KNOWN THAT BUBBLES MAY OCCUR DURING THE PROCEDURE OF TURIS-BT, AND A SMALL EXPLOSION MAY OCCUR BECAUSE OF THE BUBBLES RARELY. 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 THE PROCEDURE OF TURIS-BT, WHEN THE HIGH FREQUENCY OUTPUT WAS ACTIVATED TO CUT THE TISSUE, THE EXPLOSION OCCURRED IN THE PT BLADDER. THEN THE PHYSICIAN RE-STARTED THE PROCEDURE BY USING THE SAME DEVICES AND THE PROCEDURE WAS COMPLETED. ALSO DURING THE PROCEDURE, MANY BUBBLES OCCURRED. THE SUBJECT DEVICE WAS USED WITH (B)(4) (HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30 DEGREES, STERILE, SINGLE USE, 12 PCS., FOR TURIS). THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380956 OLYMPUS SURGMASTER ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT GEI OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other