BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9131660 · Received September 27, 2019

    Report

    Report Number
    9610877-2019-01458
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    August 30, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K161222
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 21/AUG/2019 AND INSPECTION OF THE UNIT WAS PERFORMED ON 30/AUG/2019 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, INSERTION TUBE GAUGE/DIG AT STAGE 1, PASSED DRY LEAK TEST, SHIELD COVER CORRODED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, PRIMARY OPERATION CHANNEL RESISTANCE, INSERTION TUBE ROOT BRACE BROKEN, ETO VENT VALVE LOOSE INNER SHAFT, PASSED WET LEAK TEST, SUCTION TUBE RESISTANCE, # 2 REMOTE CONTROL BUTTON COVER CRACKED, LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE CHIPPED, PRISM LENS CHIPPED, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION. 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. PARTS REPLACED: AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, SEGMENT ATTACHING SCREW, INSERTION FLEXIBLE TUBE, ROOT BRACE RUBBER, SEGMENT ASSY ATTACHING SCREW, INSERTION FLEXIBLE TUBE, ROOT BRACE RUBBER, SEGMENT ASSY ATTACHING SCREW, OBJECTIVE PRISM ASSY, RL PULLEY ASSY, UD PULLEY ASSY, REMOTE CONTROL BUTTON, LCB DISTAL COVER, EOG VALVE ASSY, SUCTION CHANNEL LG, O-RINGS AND SEALS, DISTAL CASE/CAP, DEFLECTOR BODY LINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923025 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1