BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ME718

    MDR report key: 6261314 · Received January 18, 2017

    Report

    Report Number
    9614750-2017-00005
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    January 20, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ITO CO., LTD. TSUKUBA FACTORY
    Product Code
    IMI
    PMA / PMN Number
    K112520
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE INVOLVED IN THE ADVERSE EVENT, ITO CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE: ITO INSPECTED THE APPEARANCE OF THE RETURNED DEVICE AND OBSERVED FINE SCRATCHES ON THE SURFACE AND CORROSION IN THE CENTER OF THE OSCILLATOR. ITO CONDUCTED THE FOLLOWING INSPECTIONS ON THE RETURNED DEVICE: - MEASUREMENT OF OSCILLATORY FREQUENCY: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF POWER INPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF ULTRASOUND OUTPUT: WITHIN THE PRE-DEFINED SPECIFICATIONS - SAFETY EQUIPMENT: FUNCTIONED AS PRE-DEFINED - FAN MOTOR: FUNCTIONED AS PRE-DEFINED - SHOCK TEST: PASSED - LOAD TEST: PASSED - ENVIRONMENT TEST: PASSED - MEASUREMENT OF ERA: WITHIN THE PRE-DEFINED SPECIFICATIONS - MEASUREMENT OF BNR: WITHIN THE PRE-DEFINED SPECIFICATIONS ITO SAVED ALL THE DATA IN THE INVESTIGATION REPORT ON US-101L (S/N: (B)(4)). CONCLUSION REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULT: THE SUBJECT DEVICE FUNCTIONS WITHOUT ANY ABNORMALITY. ITO REMINDED THE USER OF THE CORRECT USAGE, AS DESCRIBED IN THE USER MANUAL. THE HEALTHCARE FACILITY DID NOT DISCLOSE THE INFORMATION ON THE PATIENT'S WEIGHT.

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVING US-101L DEVICE OCCURRED IN (B)(6), BUT SIMILAR DEVICE IS MARKETED IN THE US UNDER THE BRAND NAME ME718.

    Description of Event or Problem · 1

    ULTRASOUND WAS APPLIED TO THE PATIENT'S HIP USING THE SUBJECT US-101L DEVICE AT 100% OUTPUT ON 2.00W/CM2 WITH 1MHZ FREQUENCY. THE APPLICATION WAS MADE FOR ONE MINUTE TO ONE AND A HALF MINUTES ON EACH SPOT, AND THE TOTAL APPLICATION TIME WAS FIVE MINUTES. THE ELECTRODES WERE USED IN A STROKING MOTION WITHIN A 2CM WIDTH. THE PROCEDURE STATED TO CHANGE THE APPLICATION SPOT UPON ANY ALLEGED DISCOMFORT OR PAIN BY A PATIENT. THERE WAS NO HEAT SENSATION ALLEGED BY THE PATIENT DURING THE TREATMENT. THERE WAS NO BLISTER OBSERVED AFTER THE TREATMENT, BUT A BLISTER WAS CONFIRMED A FEW DAYS LATER UPON RECEIVING A COMPLAINT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45097 ME718 ULTRASONIC DIATHERMY FOR USE IN APPLYING THERAPEUTIC DEEP HEAT IMI ITO CO., LTD. TSUKUBA FACTORY US-101L

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other