BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIGH VISION 900 ULTRASOUND

    MDR report key: 1613737 · Received January 25, 2010

    Report

    Report Number
    8030405-2010-00002
    Event Type
    Other
    Date Received
    January 25, 2010
    Date of Event
    December 29, 2009
    Report Date
    December 29, 2009
    Manufacturer
    HITACHI MEDICAL CORP.
    Product Code
    IYN
    PMA / PMN Number
    K063518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HMSA APPLICATIONS VISITED THE SITE ON (B)(6) 2010 AND DID SOME PHANTOM TESTING OF THE TWO SYSTEMS. THE COMPLAINING PHANTOM IMAGES AND THE BREAST EXAM IN QUESTION WERE REVIEWED BY OUR ULTRASOUND CLINICAL SCIENCE MGR. IN HER OPINION, THE PHANTOM IMAGES WERE COMPARABLE, AS WERE THE BREAST IMAGES, EXCEPT FOR WHEN THE BIOPSY NEEDLE WAS INSERTED. IN THE IMAGES FROM THE HV900, THE LESION WAS VISIBLE UNTIL THE FRAMES SHOWING THE NEEDLE. HITACHI BELIEVES, BASED ON THE PHANTOM IMAGES AND GENERAL IMAGE QUALITY, THAT THE HV 900 SYSTEM IS PERFORMING TO SPECIFICATION. APPLICATIONS VISITED THE SITE AGAIN ON (B)(6) 2010, AND MONITORED TWO CASES, AND AGAIN ON (B)(6) 2010 AND MONITORED 6 CASES. ALL OF THE CASES WERE SUCCESSFULLY IMAGED, BUT NONE PRESENTED A SMALL LESION COMPARABLE TO THE CASE ON (B)(6) 2010. HITACHI IS CONTINUING TO WORK WITH THE SITE, BUT CANNOT COME TO A CONCLUSION AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2009, HITACHI RECEIVED A CALL FROM THE SITE CLAIMING THAT THE HITACHI HV 900 ULTRASOUND WAS NOT ABLE TO VISUALIZE A SMALL BREAST LESION THAT WAS SUCCESSFULLY IMAGED ON A SIEMENS SEQUOIA ULTRASOUND SYSTEM OWNED BY THE FACILITY. ON THE STUDY IN QUESTION, A SONOGRAPHER FIRST IMAGED THE PT ON THE SEQUOIA, THEN THE PT WAS MOVED TO THE HV 900, WHICH IS USED FOR BIOPSIES, WHERE THE DOCTOR OPERATED THE SYSTEM INSTEAD. THE DOCTOR HAD DIFFICULTY VISUALIZING THE LESION ON THE HV 900 AS THE BIOPSY NEEDLE WAS INSERTED. THERE WAS NO INJURY REPORTED. ACCORDING TO THE INFO HITACHI RECEIVED, THE DOCTOR WAS ABLE TO COMPLETE THE BIOPSY OF THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH VISION 900 ULTRASOUND MAGNETIC RESONANCE DIAGNOSTIC DEVICE IYN HITACHI MEDICAL CORP. HV 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other