BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9096883 · Received September 20, 2019

    Report

    Report Number
    9610877-2018-00447
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Report Date
    September 22, 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
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4) 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 (B)(4) 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. (B)(4). NOTES: INITIAL MDR ORIGINALLY SUBMITTED TO THE FDA ON 10OCT2018, HOWEVER, THERE WAS AN ERROR IN FDA ACKNOWLEDGEMENT. RESUBMITTING ON AS PART OF A DELIVERY MESSAGE REVIEW.

    Description of Event or Problem · 1

    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 ((B)(4)). 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 LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 18/SEP/2018 WITH NO REPORT OF CONCERNS. INSPECTION OF THE UNIT WAS PERFORMED ON 22/SEP/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: INSERTION TUBE SEVERE DISCOLORATION AT STAGE 1, DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, BENDING RUBBERSEVERE DISCOLORATION, PASSED DRY LEAK TEST, REMOTE CONTROL BUTTON CASE LID DISCONNECTED, PASSED WET LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, FLUID INVASION IN PVE CONNECTOR, INSERTION TUBE GAUGE/DIG AT STAGE 2, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, ELEVATOR KNOB CLICKING SOUND, CUSTOMER COMPLAINT CONFIRMED, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION, 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 INCLUD THE DISTAL CASE/CAP, WHICH WAS REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO INVENTORY. PARTS REPLACED: OPERATION CHANNEL, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, DISTAL CASE/CAP, RL PULLEY ASSY, UD PULLEY ASSY, REMOTE CONTROL BUTTON, INSERTION FLEXIBLE TUBE, DEFLECTOR BODY LINK, O-RING(0.5X1.3), AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR LEVER, DEFLECTOR STAYCOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893092 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1