BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3D OCT-1 MAESTRO

    MDR report key: 19111294 · Received April 15, 2024

    Report

    Report Number
    9614661-2024-00001
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 11, 2024
    Manufacturer
    TOPCON CORPORATION
    Product Code
    OBO
    PMA / PMN Number
    K170164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TOPCON IS IN THE PROCESS OF CONTACTING THE HOSPITAL WHERE THE INCIDENT OCCURRED TO FURTHER INVESTIGATE. AN INVESTIGATION OF THE DEVICE IS PLANNED, BUT HAS NOT YET BEEN PERFORMED.

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION CONFIRMED THAT THERE WERE NO MALFUNCTIONS WITH THE PRODUCT. THE DOCTOR WASN'T AWARE THAT THE PATIENT HAD A PRE-EXISTING CONDITION OF EPILEPSY, NOR THAT THE PATIENT HAD AN EPILEPTIC SEIZURE AFTER THE TEST. (ONLY THAT THE PATIENT WAS FEELING SICK.) PER THE DOCTOR'S COMMENT, IT IS NORMAL FOR EPILEPSY PATIENTS TO HAVE SEIZURES. EPILEPTIC SEIZURES ARE NOT LIMITED TO FUNDUS PHOTOGRAPHY BUT DEVELOP WHEN SUBJECTED TO EXTERNAL FACTORS. IN THIS CASE, THE POSSIBILITY THAT THE EPILEPTIC SEIZURE WAS CAUSED BY FUNDUS PHOTOGRAPHY CANNOT BE RULED OUT. IT IS BASIC KNOWLEDGE THAT ANY DOCTOR IS AWARE THAT EPILEPTIC PATIENTS MAY DEVELOP SEIZURES WHEN SUBJECTED TO EXTERNAL FACTORS (FUNDUS PHOTOGRAPHY INCLUDED). THE DOCTOR WAS MINDFUL OF THE RISK OF INDUCING EPILEPTIC SEIZURES BY THE DEVICE TESTING. IF THE DOCTOR HAD KNOWN THAT THE PATIENT HAD A PRE-EXISTING CONDITION OF EPILEPSY, SHE COULD HAVE TAKEN ACTION TO AVOID THE DEVICE TESTING. ALTERNATIVELY, IF THE DOCTOR HAD DETERMINED THAT THE TEST WAS NECESSARY EVEN WITH THE RISK OF DEVELOPING SEIZURES, THE TEST COULD HAVE BEEN PERFORMED UNDER THE DOCTOR'S SUPERVISION TO ENSURE SAFETY. IN THIS CASE, IT IS CONCLUDED THAT THE PATIENT FAILED TO INFORM THE DOCTOR OF HER EPILEPSY CONDITION AND FAILED TO COMMUNICATE HER SYMPTOMS ADEQUATELY WITH THE DOCTOR WHEN THE SEIZURE DEVELOPED AFTER DEVICE TESTING. AS A RESULT, PROMPT TREATMENT WAS NOT PERFORMED FOR THE SEIZURE BY THE DOCTOR, THEREFORE THE PATIENT CLAIMED, "SEVERE SEIZURE CAUSED AFTER THE TESTING". ANY SIMILAR EVENTS WITH THE SAME DEVICE HAVE NOT BEEN RECEIVED TO DATE. ADDITIONALLY, SINCE SIMILAR EVENTS HAVE NOT BEEN REPORTED IN PREVIOUS LITERATURE THE SEIZURE MAY HAVE OCCURRED COINCIDENTLY; HOWEVER, THERE IS NO EVIDENCE TO SUBSTANTIATE IT. THE PATIENT'S SYMPTOMS OF EPILEPTIC SEIZURES THAT INSISTED ON STAYING IN BED FOR TWO WHOLE DAYS AND ADDITIONAL MEDICATION INSTRUCTED BY THE DOCTOR (A DIFFERENT DOCTOR FROM THE EYE CLINIC) WERE BASED SOLELY ON INFORMATION PROVIDED BY THE PATIENT ONLY, NO INFORMATION FROM THE DOCTOR COULD BE OBTAINED. THE MANUFACTURER DETERMINED THAT FURTHER INVESTIGATION WOULD BE DIFFICULT TO ASSESS THE SEIZURE SEVERITY. BASED ON THE ABOVE, IT IS IMPOSSIBLE TO PROVIDE A CLEAR RATIONALE FOR BOTH SERIOUS AND NON-SERIOUS, SO THE MANUFACTURER JUDGED THIS EVENT AS "SERIOUS".

    Description of Event or Problem · 0

    THE INJURED PATIENT PERSONALLY REPORTED TO TOPCON THAT THEY ATTENDED AN EYE EXAM INVOLVING TOPCON'S 3D OCT-1 MAESTRO. UPON RECEIVING A FLASH OF LIGHT FROM THE DEVICE, THE PATIENT REPORTED EXPERIENCING AN EPILEPTIC SEIZURE WHILE IN THE EXAMINATION ROOM. FOLLOWING THE SEIZURE, THE PATIENT DESCRIBES NOT BEING GIVEN FIRST AID OR OFFERED AN AMBULANCE AND INSTEAD BEING INFORMED THAT THE NEXT PATIENT WAS BEING CALLED FOR THEIR EXAMINATION. THE PATIENT CALLED A TAXI TO RETURN HOME, BUT STATES THEY FELL AND FRACTURED THEIR RIBS ON THE ELBOW REST OF THEIR WHEELCHAIR WHILE GETTING INTO THE TAXI. THE PATIENT FURTHER REPORTS EXPERIENCING SEIZURES SEVERAL TIMES A DAY FOLLOWING THE INCIDENT DURING THE EYE EXAM. THE PATIENT LATER STATED THAT THEY EXPERIENCED HEADACHES AND DIZZINESS FOR TWO DAYS FOLLOWING THE INCIDENT AFTER WHICH TIME THEY CONTACTED THEIR DOCTOR AND WERE INSTRUCTED TO INCREASE THE DOSAGE OF THEIR [UNSPECIFIED] MEDICATION. THE PATIENT WAS NOT HOSPITALIZED AND RESTED UNTIL THE SIDE EFFECTS OF THE SEIZURE SUBSIDED. THE PATIENT ALSO VISITED THE DOCTOR TO EVALUATE THE INJURED RIB AT WHICH TIME IT WAS CONFIRMED TO BE FRACTURED. NO HOSPITALIZATION OCCURRED, BUT THE PATIENT WAS PRESCRIBED PAIN KILLERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063091 3D OCT-1 MAESTRO OPTICAL COHERENCE TOMOGRAPHER OBO TOPCON CORPORATION 470109900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other