BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8588214 · Received May 7, 2019

    Report

    Report Number
    9610877-2019-00218
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Report Date
    December 3, 2018
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BASED ON DISCUSSION WITH FDA ON MAY 8, 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).

    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). BASED ON DISCUSSION WITH FDA ON MAY 8, 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. CORRECTION: DATES CHANGED FROM 28NOV2019 TO 28NOV2018, FROM 03DEC2019 TO 03DEC2018, AND FROM 03DEC2019 TO 03DEC2018.

    Description of Event or Problem · 0

    PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-001-C WHICH INCLUDED INSPECTION OF THE SEAL AROUND THE DISTAL BODY AND DISTAL CAP OF THE ED-3490TK DUODENOSCOPE PURSUANT TO PREDEFINED INSPECTION CRITERIA (ET-HF-P-0013 REV. 00). THE OBJECTIVE OF THE INSPECTION WAS TO VERIFY THERE WERE NO DEFECTS/DISCONTINUITIES IN THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP. THE INSPECTIONAL CRITERIA WAS DEFINED AS, "ALL SEAL SURFACES OBSERVED SHALL BE CONTINUOUS AND SMOOTH WITH NO OUTWARD SIGNS OF DISCONTINUITY, GAPS OR BUBBLES." A DEVICE WAS CONSIDERED TO FAIL THE INSPECTION IF ANY ELEMENT OF THE CRITERIA WAS NOT MET. THE CUSTOMER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 28/NOV/2018 AND INSPECTION OF THE UNIT WAS PERFORMED ON 03/DEC/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION; IMAGE SPOTS; PASSED WET LEAK TEST; LIGHTGUIDE PRONG COVER GLASS SET LOOSE; PASSED DRY LEAK TEST; 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 WAS REPAIRED WHERE DISTAL CASE/CAP, WAS REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO USER ON 25/JAN/2019. PARTS REPLACED: O-RINGS AND SEALS; OBJECTIVE PRISM ASSY; DEFLECTOR BODY LINK; DISTAL CASE/CAP; O-RING (0.5X1.3); DISTAL ATTACHING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380460 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1