BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG-G2

    MDR report key: 3063189 · Received February 27, 2013

    Report

    Report Number
    8010047-2013-00046
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 12, 2013
    Report Date
    December 25, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVAL. THE EVAL 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 MFG HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE EVAL 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 W/O 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 INFO GIVEN THERE DOES NOT ELIMINATE THE ABNORMALITY, TERMINATE THE USE OF THE EQUIPMENT AND CONTACT OLYMPUS. IF ADD'L INFO IS REC'D, THIS REPORT WILL BE SUPPLEMENTED.

    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 #8010047-2013-00046 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 A PHYSICIAN ATTEMPTED TO USE THE SUBJECT DEVICE FOR A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY, THE FOOTSWITCH FOR OUTPUT DIDN'T WORK. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85291 SONOSURG-G2 ULTRASONIC SURGICAL SYSTEM LFL OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG-G2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1