BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10062244 · Received May 15, 2020

    Report

    Report Number
    3004972322-2020-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2020
    Date of Event
    September 27, 2019
    Report Date
    July 1, 2020
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K160108
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENT REPORT #1- JULY 01, 2020. ON JUNE 30, 2020 FUJIFILM MEDICAL SYSTEMS USA, INC. RECEIVED A CLASSIFICATION COMMUNICATION FROM THE FDA FOR THE RECALL. UPDATED INFORMATION IS BEING PROVIDED IN SECTIONS H7 (RECALL), H9 (C&R NUMBER: 1000513161-06/01/2020-001-C, FDA RECALL NUMBER: Z-2471-2020). IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2019, FUJIFILM MEDICAL SYSTEMS USA, INC. SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS TOMO MARKERS AND WAS DETERMINED NOT TO BE A COMPLAINT BASED ON THE SERVICE TICKET. ON JANUARY 24, 2020, FUJIFILM MEDICAL SYSTEMS USA, INC. ENGINEERING DEPARTMENT WAS NOTIFIED OF CUSTOMER CONCERNS REGARDING SYNAPSE PACS TOMO ISSUES. INITIAL INVESTIGATION INDICATED THAT THE ORIENTATION MARKER WAS BEING DISPLAYED ON THE WRONG SIDE OF THE TOMO IMAGE. THE RESOLUTION WAS PROVIDED THROUGH A BUG FIX. BASED ON RISK AND SEVERITY OF THE ISSUE AND FIX, THE COMPLAINT WAS DETERMINED NOT TO BE REPORTABLE. ON APRIL 1, 2020, FUJIFILM MEDICAL SYSTEMS USA, INC QUALITY AND REGULATORY DEPARTMENT WAS NOTIFIED OF CUSTOMER CONCERNS REGARDING ADDITIONAL SYNAPSE PACS TOMO ISSUES. UPON FURTHER INVESTIGATION, ON APRIL 28, 2020 IT WAS DETERMINED THAT THERE WERE THREE (3) ISSUES WITH THE LATERALITY. ISSUE 1: INDICATORS WERE MISSING ON LXCCL, RXCCL, LLMO, AND RLMO. THIS ISSUE WAS FIXED IN VERSION 5.7, HOWEVER, HAVING THE REFERENCE POINTS ON THE SLIDE BAR BROUGHT ANOTHER ISSUE TO LIGHT. ISSUE 2: THE LLMO AND RLMO ARE DISPLAYING LATERALITY INCORRECTLY BECAUSE THE LATERAL AND MEDIAL REFERENCE POINTS WERE SWITCHED, THE SLIDE BAR WAS IN THE INCORRECT DIRECTION, ISSUE 3: THE IMAGE COUNT WAS DISPLAYING IN REVERSE ORDER. THERE WAS NO PATIENT SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS REPLICATED IN THE FUJIFILM MEDICAL SYSTEMS USA LAB. THE CAUSE WAS TRACED TO THE SOFTWARE NOT READING THE CORRECT DICOM TAB FOR BREAST TOMO IMAGES. A BUG FIX HAS BEEN DEVELOPED AND ALL AFFECTED CUSTOMERS WILL BE NOTIFIED OF THE ISSUE AND PROVIDED THE FIX. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON SEPTEMBER 27, 2019, FUJIFILM MEDICAL SYSTEMS USA, INC. SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS TOMO MARKERS AND WAS DETERMINED NOT TO BE A COMPLAINT BASED ON THE SERVICE TICKET. ON JANUARY 24, 2020, FUJIFILM MEDICAL SYSTEMS USA, INC. ENGINEERING DEPARTMENT WAS NOTIFIED OF CUSTOMER CONCERNS REGARDING SYNAPSE PACS TOMO ISSUES. INITIAL INVESTIGATION INDICATED THAT THE ORIENTATION MARKER WAS BEING DISPLAYED ON THE WRONG SIDE OF THE TOMO IMAGE. THE RESOLUTION WAS PROVIDED THROUGH A BUG FIX. BASED ON RISK AND SEVERITY OF THE ISSUE AND FIX, THE COMPLAINT WAS DETERMINED NOT TO BE REPORTABLE. ON APRIL 1, 2020, FUJIFILM MEDICAL SYSTEMS USA, INC QUALITY AND REGULATORY DEPARTMENT WAS NOTIFIED OF CUSTOMER CONCERNS REGARDING ADDITIONAL SYNAPSE PACS TOMO ISSUES. UPON FURTHER INVESTIGATION, ON APRIL 28, 2020 IT WAS DETERMINED THAT THERE WERE THREE (3) ISSUES WITH THE LATERALITY. ISSUE 1: INDICATORS WERE MISSING ON LXCCL, RXCCL, LLMO, AND RLMO. THIS ISSUE WAS FIXED IN VERSION (B)(4), HOWEVER, HAVING THE REFERENCE POINTS ON THE SLIDE BAR BROUGHT ANOTHER ISSUE TO LIGHT. ISSUE 2: THE LLMO AND RLMO ARE DISPLAYING LATERALITY INCORRECTLY BECAUSE THE LATERAL AND MEDIAL REFERENCE POINTS WERE SWITCHED, THE SLIDE BAR WAS IN THE INCORRECT DIRECTION, ISSUE 3: THE IMAGE COUNT WAS DISPLAYING IN REVERSE ORDER. THERE WAS NO PATIENT SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524450 SYNAPSE PACS SYNAPSE PACS LLZ FUJIFILM MEDICAL SYSTEMS U.S.A., INC. N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1