BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12637319 · Received October 14, 2021

    Report

    Report Number
    9610877-2021-01233
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 10, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE PROCESS PCB MALFUNCTION. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO AN EXCESSIVE SHOCK APPLIED ON THE PROCESS PCB. CORRECTION INFORMATION: G6: FOLLOW UP #1. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-3000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    A TROUBLE OCCURRED FROM THE FACILITY. REPLACEMENT OF SUBSTITUTES WAS CARRIED OUT. CHECK ERROR LOG 03-0200. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528042 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown