BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    MDR report key: 5182849 · Received October 28, 2015

    Report

    Report Number
    8010047-2015-01001
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 5, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K021962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE SUBJECT DEVICE DID NOT TURN ON, ONE OF THE TWO FUSES WAS BLOWN, AND FET (FIELD-EFFECT TRANSISTOR) OF AMPLIFIER SUBSTRATE WAS DAMAGED. THE MANUFACTURING RECORDS FOR THIS SERIAL NUMBER INDICATED NO ABNORMALITIES RELATED TO THE REPORTED PHENOMENON. BASED UPON THE EVALUATION RESULT, IT WAS SUPPOSED THAT THE BURNT SMELL AND THE SMOKE OCCURRED SINCE THE FET WAS DAMAGED, AND THEN THE SUBJECT DEVICE SHUT DOWN DUE TO THE BLOWN FUSE. IT IS CONSIDERED THAT THE FET WAS DAMAGED SINCE THE ELECTRIC CURRENT LEAKED EXCESSIVELY IN THE FET. AMOUNT OF THE LEAKED ELECTRIC CURRENT DEPENDS ON THE DISPERSION IN THE ELECTRICAL CHARACTERISTIC OF FET. OMSC ADDRESSED THIS PHENOMENON BY REDUCING THE DISPERSION OF FET. THE SUBJECT DEVICE INSTRUCTION MANUAL STATES THE FOLLOWING. PREPARE A SPARE INSTRUMENT AS A BACKUP TO ENSURE THAT THE PROCEDURE CAN BE COMPLETED WITHOUT COMPLICATIONS IN CASE OF A MALFUNCTION.

    Description of Event or Problem · 1

    WHEN THE SUBJECT DEVICE WAS USED DURING A PROCEDURE, THE USER SMELLED THE BURNT SMELL, AND SMOKE OCCURRED. THE USER STOPPED USING THIS DEVICE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714913 ULTRASONIC SURGICAL SYSTEM SONOSURG ELECTROSURGICAL UNIT LFL OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG-G2

    Patients

    Seq Age Sex Outcome Treatment
    1