BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3D VISUALIZATION UNIT

    MDR report key: 15169248 · Received August 4, 2022

    Report

    Report Number
    3002808148-2022-00684
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 7, 2022
    Report Date
    September 19, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD
    Product Code
    FET
    UDI-DI
    04953170338229
    PMA / PMN Number
    K123365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: FULL NAME ADDRESS OF THE CUSTOMER IS (B)(6). THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED . THE REPORTED CUSTOMER ISSUE OF INTERMITTENT, NO SIGNAL IN THE IMAGE WAS NOT ABLE TO BE DUPLICATED. DEVICE EVALUATION AND INSPECTION, THE FOLLOWING FINDINGS WERE NOTED: DURING THE INSPECTION AT OLYMPUS CHINA (REPAIR CENTER) RC, THE SUBJECT DEVICE WAS KEPT RUNNING FOR ONE WEEK TO CHECK, AND THE REPORTED FAULT WAS NOT REPRODUCED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM THE UPDATES/CORRECTION ON SECTION D3 FROM THE INITIAL MDR REPORT. MANUFACTURER NAME AND ADDRESS IS BEING UPDATE AS BELOW: PLEASE REFER TO SECTION D3 FOR UPDATED INFORMATION AS WELL. AIZU OLYMPUS CO., LTD. WAS UPDATED AND CHANGED TO SHIRAKAWA OLYMPUS CO., LTD AS THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PLEASE SEE UPDATES TO H4, H6 AND H10. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED EVENT (INTERMITTENT IMAGE) WAS UNABLE TO BE DUPLICATED DURING THE DEVICE EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THERE IS AN INTERMITTENT NO SIGNAL IN THE IMAGE, AND THE SIGNAL IS NORMAL AFTER RESTARTING THE 3DV PROCESSOR . THE INTENDED PROCEDURE (URINARY TRACT LITHOTRIPSY) WAS COMPLETED WITH THE SAME DEVICE WITH NO PATIENT HARM AND NO INJURY REPORTED. NO USER INJURY REPORTED . NO DELAY IN THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930030 3D VISUALIZATION UNIT 3D VISUALIZATION UNIT FET SHIRAKAWA OLYMPUS CO., LTD 3DV-190 04953170338229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CV-190