BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG-G2

    MDR report key: 2927785 · Received December 18, 2012

    Report

    Report Number
    8010047-2012-00466
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 4, 2012
    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 #8010047-2012-00466 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 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. BUT IT WAS NOT KNOWN EXACTLY CAUSE. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE EVALUATION RESULT OF THE SUBJECT DEVICE BY OMSC, SINCE THE INCIDENTAL MALFUNCTION OF FET OCCURRED OR THERE WAS SOMETHING THE WRONG WITH THE ELECTRICAL POWER ENVIRONMENT OF FACILITY, FET WAS DAMAGED AND THE FUSES BLEW. THE SONOSURG-G2 INSTRUCTION MANUAL ALREADY STATES: WARNING: PREPARE A SPARE INSTRUMENT AS A BACKUP TO ENSURE THAT THE PROCEDURE CAN BE COMPLETED WITHOUT COMPLICATIONS IN CASE OF A MALFUNCTION. WARNING: IF YOU SUSPECT ANY ABNORMALITY WHILE USING THIS PRODUCT, IMMEDIATELY STOP THE PROCEDURE. REFER TO CHAPTER 7, "TROUBLESHOOTING" AND THE INSTRUCTION MANUAL OF THE SONOSURG HAND PIECE BEING USED. IF THE INFORMATION GIVEN THERE DOES NOT ELIMINATE THE ABNORMALITY, TERMINATE THE USE OF THE EQUIPMENT AND CONTACT OLYMPUS. 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

    WHEN A PHYSICIAN ATTEMPTED TO USE THE SUBJECT DEVICE FOR AN ABDOMINAL SURGERY, THE SUBJECT DEVICE WAS AUTOMATICALLY POWERED DOWN AFTER 5 HOURS. THE PHYSICIAN CONTINUED THE PROCEDURE AND THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1