BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8732488 · Received June 25, 2019

    Report

    Report Number
    9610877-2019-00341
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Report Date
    June 5, 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
    AL, US
    Reporter Occupation
    003

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

    Description of Event or Problem · 0

    THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 04/JUN/2019 AND INSPECTION OF THE UNIT WAS PERFORMED ON 05/JUN/2019 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION. LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE. RIGHT /LEFT ANGULATION KNOB PLAY. FORWARD BODY TRIM COLLAR ATTACHING NUT WORN/ LOOSE THREAD. PRISM SCRATCHED. FAILED DRY LEAK TEST. UP/ DOWN BRAKE LEVER BROKEN. FAILED WET LEAK TEST. IMAGE SPOTS. DISTAL CAP/ CASE CRACKED. UP/ DOWN ANGULATION KNOB PLAY. DISTAL CAP - FIXED TYPE K1 - ZONE K - SEAL INTEGRITY INTACT. HOLE IN # 2 REMOTE CONTROL BUTTON COVER. OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY. UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE SCRATCHED. SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED. CUSTOMER COMPLAINT CONFIRMED. FLUID INVASION NOT OBSERVED IN PVE CONNECTOR. FLUID INVASION NOT OBSERVED IN CONTROL BODY. INSPECTION OF THE 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, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO THE CUSTOMER UPON COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525634 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1