BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8671385 · Received June 5, 2019

    Report

    Report Number
    9610877-2019-00329
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Report Date
    May 10, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4) PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036). DATE OF AWARENESS WAS CORRECTED TO MAY 10, 2019.

    Additional Manufacturer Narrative · 1

    (B)(4) (EXEMPTION NUMBER E2015036). BASED ON DISCUSSION WITH FDA ON MAY 8, 2017, ALL INSPECTIONAL FAILURES ARE BEING REPORTED AS MDRS NOT WITHSTANDING THE FACT THAT THE PRESENCE OF DISCONTINUITIES, GAPS OR BUBBLES DOES NOT NECESSARILY HAVE EITHER TECHNICAL OR CLINICAL SIGNIFICANCE. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS PREVIOUSLY RETURNED TO PENTAX (B)(4) FROM A CUSTOMER. INSPECTION OF THE EPOXY SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE SCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463008 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1