BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY ODM

    MDR report key: 15869003 · Received November 28, 2022

    Report

    Report Number
    3013986459-2022-00001
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 23, 2022
    Manufacturer
    TOPCON HEALTHCARE SOLUTIONS, INC
    Product Code
    NFJ
    UDI-DI
    00852683007018
    PMA / PMN Number
    K151952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONSULTATION BETWEEN A TECHNICIAN AND THE PHYSICIAN TO DETERMINE WHETHER ANY PARTICULAR WORKFLOW CONTRIBUTED TO THE ERROR PROVED TO BE INCONCLUSIVE. THE REMAINING HYPOTHESIS IS THAT AN ERROR OCCURRED IN THE USER'S BROWSER CACHE THAT RESULTED IN THIS ERROR, BUT SINCE THE CACHE IS NOT MAINTAINED THIS CANNOT BE VERIFIED. THE CUSTOMER IMPACTED BY THIS ERROR WILL BE TRANSITIONED TO AN ALTERNATIVE SOFTWARE SOLUTION TO PREVENT ANY REOCCURRENCE THAT MAY BE CAUSED BY THE USER ENVIRONMENT OR USER WORKFLOW. CORRECTED DATA: B1: CORRECTED TO "ADVERSE EVENT". B2: CORRECTED TO "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE". B5: ADDED NEW INFORMATION. H1: CORRECTED TO "SERIOUS INJURY". H6: CORRECTED CLINICAL CODE TO 4471, "UNSPECIFIED EYE/VISION PROBLEM"; CORRECTED IMPACT CODE TO 4629, "DEVICE REVISION OR REPLACEMENT". H10: ADDED NEW INFORMATION TO NARRATIVE.

    Additional Manufacturer Narrative · 0

    SYNERGY ODM IS A DISCONTINUED SAMD WITH ONLY 11 INSTANCES REMAINING IN THE UNITED STATES. DURING THE INITIAL INVESTIGATION, TOPCON SUPPORT AND ENGINEERING REMOTED DIRECTLY INTO THE CUSTOMER'S ENVIRONMENT TO ATTEMPT REPRODUCTION OF THE ISSUE. THE EXAM IN QUESTION WAS PRINTED CORRECTLY, AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. IT WAS NOTED THAT PATIENT "MR" DID NOT HAVE ANY IMAGES STORED IN SYNERGY AND NO LINK BETWEEN THE TWO PATIENTS COULD BE FOUND VIA A DATABASE SEARCH. TOPCON HAS MADE MULTIPLE REQUESTS TO THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE WORKFLOW USED BY THE CUSTOMER SO THAT ANOTHER ATTEMPT CAN BE MADE TO REPRODUCE THE ISSUE AND IDENTIFY THE CAUSE, BUT NO FEEDBACK HAS BEEN PROVIDED TO TOPCON. THE CUSTOMER WAS ALSO ASKED WHY A PATIENT AGREED TO HAVE A SURGERY PERFORMED IF, AS FOUND BY TOPCON ENGINEERING, THERE ARE NO IMAGES OR EXAM RECORDS UNDER THE PATIENT'S ID IN SYNERGY, BUT NO RESPONSE HAS BEEN PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A CORRECTIVE SURGERY TO HAVE THEIR BILATERAL LENSES REPLACED WITH THOSE OF THE CORRECT PRESCRIPTION. THIS CORRECTIVE SURGERY OCCURRED THE DAY AFTER THE INITIAL INCIDENT, AND NO POST-OPERATION ISSUES HAVE BEEN REPORTED SINCE THEN.

    Description of Event or Problem · 0

    THE END USER REPORTED THAT SYNERGY SOFTWARE PRINTED THE INCORRECT PATIENT NAME (PATIENT MR) IN THE HEADER OF THE EXAM FOR ANOTHER PATIENT (LA) RESULTING IN TWO NAMES PRESENT ON A SINGLE PAGE. THE END USER REPORTED THAT THIS RESULTED IN A MIS-DIAGNOSIS AND IMPROPER SURGERY FOR THE PATIENT (MR). THE TYPE OF SURGERY PERFORMED AND INFORMATION REGARDING THE PATIENT OUTCOME INCLUDING WHETHER THERE WILL BE ANY PERMANENT CONSEQUENCES OR WHETHER ADDITIONAL SURGERY WAS NECESSARY TO CORRECT THE PATIENT REMAINS UNKNOWN IN SPITE OF MULTIPLE REQUESTS TO DISCLOSE THIS INFORMATION. TOPCON HEALTHCARE SOLUTIONS SUPPORT WAS UNABLE TO REPRODUCE THE ISSUE WHEN REMOTED INTO THE CUSTOMER'S ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053684 SYNERGY ODM OPHTHALMIC IMAGE MANAGEMENT SYSTEM NFJ TOPCON HEALTHCARE SOLUTIONS, INC 4.06.004.14719 00852683007018

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention