BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI VISION 5500 ULTRASOUND

    MDR report key: 1679480 · Received May 6, 2010

    Report

    Report Number
    8030405-2010-00007
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 8, 2010
    Manufacturer
    HITACHI MEDICAL CORP
    Product Code
    IYN
    PMA / PMN Number
    K061608
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALIGNMENT OF THE STEPPER/GRID ASSEMBLY IS NOT A USER FUNCTION. WHEN NOTIFIED OF THE PROBLEM, WE BELIEVED THAT THE ERROR WAS DUE TO THE LACK OF CALIBRATION. HITACHI APPLICATIONS VISITED THE SITE ON (B)(6) 2010 TO CALIBRATE THE HV 5500 SYSTEM PROBE TO THE NEW STEPPER/GRID. UPON LEAVING, WE BELIEVED THAT THE RE-CALIBRATION WAS SUCCESSFUL. IN ADDITION, IT WAS LEARNED THAT THE CUSTOMER DID NOT RE-CALIBRATE THE NEEDLE GUIDE TEMPLATE GRID AND THE STEPPER/NEEDLE GUIDE TEMPLATE AS INSTRUCTED IN THE Q1E-EA0611 INSTRUCTION MANUAL BEFORE TREATING THE BRACHYTHERAPY. ON (B)(6) 2010, THE SITE CALLED BACK AND CLAIMED THAT THE ALIGNMENT WAS STILL OFF BY 1 DEGREE AND THOUGHT THE US33 PROBE WAS AT FAULT. HITACHI REQUESTED THAT THE PROBE BE RETURNED TO US FOR TESTING. THE SITE HAS NOT RETURNED THE PROBE TO DATE. AT THIS TIME, HITACHI DOES NOT KNOW THE ROOT CAUSE OF THIS ISSUE AND WILL NOT BE ABLE TO MAKE A DETERMINATION UNTIL THE PROBE IS RETURNED AND EVALUATED. WE HAVE NO RECORD OF SIMILAR COMPLAINTS IN THE PAST. IF OUR INVESTIGATION DETERMINES THAT THE PROBE WAS THE ROOT CAUSE OF THE ALIGNMENT PROBLEM, WE WILL SEND AN UPDATED REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE CUSTOMER REPORTED THAT THE BRACHY GRID DISPLAY ON HIS HITACHI HI VISION 5500 ULTRASOUND UNIT USING THE U533 PROBE IS NOT MATCHING UP WITH THE PHYSICAL GRID MOUNTED TO THEIR CIVCO BRACHY STEPPER. THE DISPLAY GRID PROVIDES A POSITIONAL OVERLAY ON THE ULTRASOUND IMAGE AND MUST MATCH THE PHYSICAL GRID TO ALLOW ACCURATE SEED PLACEMENT. THE SITE BELIEVES THE ERROR AFFECTED TWO BRACHY CASES THAT WERE FOUND TO BE FLAWED DURING POST PT FOLLOW-UP BY CT. THE SITE FOUND THE NEEDLE/GRID ALIGNMENT ON THE 5500 DISPLAY WAS OFF CONSIDERABLY. THE SITE INDICATED THAT THE TWO AFFECTED PTS MAY NEED MORE TREATMENT. AFTER EXPLAINING THAT THE CALIBRATION OF THE ASSEMBLY TYPICALLY DOESN'T CHANGE, THE SITE SAID THAT THEY HAD A DAMAGED U533 REPLACED AND THE REPLACEMENT PROBE WAS CALIBRATED WITH THE EXISTING HARDWARE. WE ALSO LEARNED THAT THEY HAD A DAMAGED CIVCO STEPPER ASSEMBLY THAT WAS SENT TO CIVCO FOR REPAIR. CIVCO SENT THE SITE A UNIT ON LOANER THAT WAS USED DURING THESE TWO CASES. THE SITE SAID THE STEPPER/GRID WAS NOT RECALIBRATED WITH THE U533 PROBE UPON ARRIVAL. NO OTHER BRACHY CASES HAVE BEEN SCHEDULED SINCE THE PROBLEM WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI VISION 5500 ULTRASOUND SYSTEM, IMAGING, PULSEDDOPPLER, ULTRASOUND IYN HITACHI MEDICAL CORP HI VISION 5500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other