BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG-G2

    MDR report key: 3657146 · Received November 27, 2013

    Report

    Report Number
    8010047-2013-00582
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    November 11, 2013
    Report Date
    December 25, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON DECEMBER 3, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2013-00582 TO PROVIDE DEVICE EVALUATION RESULTS. OLYMPUS PERFORMED FURTHER INVESTIGATION FOR THE CAUSE OF THE FET (FIELD EFFECT TRANSISTOR) DAMAGE AND THE DAMAGED FET HAD EXCESSIVE CURRENT LEAKAGE. THE AMOUNT OF THE LEAKAGE CURRENT DEPENDS ON THE ELECTRICAL CHARACTERISTIC VARIABILITY OF THE FET. OLYMPUS IMPLEMENTED A COUNTERMEASURE FOR THIS PHENOMENON TO REDUCE THE ELECTRICAL CHARACTERISTIC VARIABILITY OF THE FET.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OSMC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE FUSES OF THE SUBJECT DEVICE BLEW AND FET (FIELD-EFFECT TRANSISTOR) OF AMPLIFIER SUBSTRATE WAS DAMAGED. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE EVALUATION RESULT AND THE PAST SIMILAR CASES, SINCE THERE WERE THE INCIDENTAL FAILURE OR THE VARIATION OF FET, FET WAS DAMAGED. CONSEQUENTLY, THE FUSE BLEW. IF 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

    DURING A PREPARATION FOR USE THE SUBJECT DEVICE WAS POWERED UP, A SPARK AND SMOKE WERE GENERATED. THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT AND/OR USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620269 SONOSURG-G2 ULTRASONIC SURGICAL SYSTEM LFL OLYMPUS MEDICAL SYSTEMS CORPORATION SONOSURG-G2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1