BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG-G2

    MDR report key: 3637542 · Received November 19, 2013

    Report

    Report Number
    8010047-2013-00548
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 25, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE FUSES OF THE SUBJECT DEVICE BLEW AND FET (FIELD-EFFECT TRANSISTOR) OF AMPLIFIER SUBSTRATE WAS DAMAGED. THE DAMAGE OF FET OCCURRED. 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 AND THE FUSES 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.

    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 #8010047-2013-00548 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

    WHEN THE PHYSICIAN USED THE SUBJECT DEVICE DURING A LAPAROSCOPIC INGUINAL HERNIOPLASTY, THE SUBJECT DEVICE DID NOT ACTIVATE OUTPUT AFTER 10 MINUTES. CHECKING THE SUBJECT DEVICE, THE FUSE BLEW. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600906 SONOSURG-G2 ULTRASONIC SURGICAL SYSTEM LFL OLYMPUS MEDICAL SYSTEMS CORPORATION SONOSURG-G2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1