BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12485800 · Received September 16, 2021

    Report

    Report Number
    9610877-2021-00937
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 10, 2021
    Report Date
    December 23, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE ELEVATOR MUST BE ADJUSTED. CORRECTION INFORMATION: G6: FOLLOW UP #1. H2: TYPE OF FOLLOW UP. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 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 ED34-I10T2-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245.

    Description of Event or Problem · 0

    DURING THE INCOMING INSPECTION PENATX (B)(4) DETECTED AN ELEVATOR THAT DID NOT REACH 90?¿ THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382880 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown