BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12756359 · Received November 7, 2021

    Report

    Report Number
    9610877-2021-01434
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 20, 2021
    Report Date
    February 16, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION H4:DEVICE MANUFACTURE DATE EVALUATION SUMMARY BRAND NEW EPK-I7010 OPTIVISTA PROCESSOR DOES NOT RECOGNIZE I-SERIES ENDOSCOPES (ERROR:12 CANNOT DETECT ENDOSCOPE), PROBLEM FIXED AFTER REPLACING THE DEFECTIVE PREPROCESS PCB.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    BRAND NEW EPK-I7010 OPTIVISTA PROCESSOR DOES NOT RECOGNIZE I-SERIES ENDOSCOPES (ERROR:12 CANNOT DETECT ENDOSCOPE), PROBLEM FIXED AFTER REPLACING THE DEFECTIVE PREPROCESS PCB. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    BRAND NEW EPK-I7010 OPTIVISTA PROCESSOR DOES NOT RECOGNIZE I-SERIES ENDOSCOPES (ERROR:12 CANNOT DETECT ENDOSCOPE), PROBLEM FIXED AFTER REPLACING THE DEFECTIVE PREPROCESS PCB. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655258 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown