BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12133025 · Received July 8, 2021

    Report

    Report Number
    9610877-2021-10011
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 19, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333232918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: AS THE DEVICE WAS RETURNED BUT IT HAS BEEN STILL UNDER INVESTIGATION, WE WILL CONTINUE TO MONITOR IT AND CREATE A SUPPLEMENTAL REPORT IF NECESSARY. CORRECTION INFORMATION: G6: FOLLOW UP #1. H3: DEVICE EVALUATION. ADDITIONAL INFORMATION: H2: TYPE OF FOLLOW UP. H6: CODING ADDED BASED ON THE INVESTIGATION RESULT: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Additional Manufacturer Narrative · 1

    WE DIDN'T GET ANY INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I5500C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. THE DEVICE WAS RETURNED, BUT IT'S STILL UNDER INVESTIGATION,SO THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AN ERROR OCCURRED DURING INITIALIZATION OF PATIENT DATABASE, ERROR CODE 002-0006. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034304 PENTAX IMAGINA PROCESSOR (INCLUDES I-SCAN)-INT PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I5500C 04961333232918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other