BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7631275 · Received June 22, 2018

    Report

    Report Number
    9610877-2018-00323
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Report Date
    June 21, 2018
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K131028
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-008-C WHICH INCLUDED INSPECTION OF THE SUCTION ARM ON AFFECTED MODELS PURSUANT TO PREDEFINED INSPECTION CRITERIA (QS-397). THE OBJECTIVE OF THE INSPECTION WAS TO LOCATE PART C255-AB171 (SUCTION ARM) AND VERIFY IT IS NOT LOOSE. IF PART C255-AB171 (SUCTION ARM) IS FOUND LOOSE, THE DEVICE WAS CONSIDERED TO FAIL THE INSPECTION CRITERIA. THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 19/JUN/2018. INSPECTION OF THE DEVICE WAS PERFORMED ON 21/JUN/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, IMAGE BLACKOUT, FLUID INVASION IN SEGMENT SECTION, FLUID INVASION IN CONTROL BODY, PVE ELECTRICAL PIN CORRODED, FAILED DRY LEAK TEST, PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION, SEGMENT CRUSHED, PVE CONNECTOR HOUSING CORRODED, FAILED WET LEAK TEST, CCD CIRCUIT BOARD CORROSION, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, # 1 REMOTE CONTROL BUTTON COVER CRACKED, SUCTION ARM LOOSE, FLUID INVASION TO INSERTION TUBE, CUSTOMER COMPLAINT CONFIRMED, FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE, SHIELD COVER CORRODED, FLUID DAMAGE TO LIGHT CARRYING BUNDLE, CONTROL BODY MILD CORROSION INSIDE, FLUID INVASION IN PVE CONNECTOR. INSPECTION OF THE SUCTION ARM WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471499 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1575K

    Patients

    Seq Age Sex Outcome Treatment
    1