BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC SURGICAL SYSTEM SONOSURG

    MDR report key: 5466825 · Received February 29, 2016

    Report

    Report Number
    8010047-2016-00274
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 29, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    PMA / PMN Number
    K021962
    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 CORP. (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE SUBJECT DEVICE DID NOT TURN ON, TWO FUSES WERE BLOWN, AND FET (FIELD-EFFECT TRANSISTOR) OF AMPLIFIER SUBSTRATE WAS DAMAGED AND BURNT. THE MANUFACTURING RECORDS FOR THIS SERIAL NUMBER INDICATED NO ABNORMALITIES RELATED TO THE REPORTED PHENOMENON. BASED UPON THE EVALUATION RESULT, IT WAS SUPPOSED THAT THIS PHENOMENON OCCURRED SINCE THE FET WAS DAMAGED. 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

    THE SUBJECT DEVICE WAS USED FOR A PROCEDURE OF A HEART BLOOD VESSEL SURGERY. THOUGH THE USER STEPPED ON THE FOOT SWITCH, THE ACTIVATION DIDN'T OCCURRED SEVERAL TIMES. AFTER THAT THE USER IRRIGATED SONOSURG-IU THAT WAS USED TOGETHER AND STEPPED ON THE FOOT SWITCH AGAIN. THEN THE SUBJECT DEVICE SHUT DOWN WITH A STRANGE SOUND, AND SMOKE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123520 ULTRASONIC SURGICAL SYSTEM SONOSURG ELECTROSURGICAL UNIT LFL OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG-G2 SET

    Patients

    Seq Age Sex Outcome Treatment
    1