BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG-G2 SET

    MDR report key: 4379500 · Received December 24, 2014

    Report

    Report Number
    8010047-2014-01100
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    November 27, 2014
    Report Date
    December 28, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. THE EVAL CONFIRMED THAT THE TWO FUSES OF THE SUBJECT DEVICE WERE BLOWN AND FET (FIELD-EFFECT TRANSISTOR) OF AMPLIFIER SUBSTRATE WAS DAMAGED. THE MFG RECORDS FOR THIS SERIAL NUMBER INDICATED NO ABNORMALITIES RELATED TO THE REPORTED PHENOMENON. BASED UPON THE EVAL RESULT, THE TWO FUSES WERE BLOWN AND THE SUBJECT DEVICE SHUT DOWN DUE TO THE DAMAGE OF FET. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    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 7, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2014-01100 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.

    Description of Event or Problem · 1

    DURING PROCEDURE, THE SUBJECT DEVICE SHUT DOWN. UPON THE INVESTIGATION, THE FUSE WAS FOUND TO BE BLOWN. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850014 SONOSURG-G2 SET ULTRASONIC SURGICAL SYSTEM LFL OLYMPUS MEDICAL SYSTEMS CORPORATION SONOSURG-G2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1