BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9128682 · Received September 27, 2019

    Report

    Report Number
    9610877-2018-00342
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Report Date
    July 12, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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 27JUL2018, 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 CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 11/JUL/2018 AND INSPECTION OF THE UNIT WAS PERFORMED ON 12/JUL/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: INSERTION TUBE GAUGE/DIG AT STAGE 1. PRIMARY OPERATION CHANNEL RESISTANCE. UP/ DOWN ANGULATION KNOB PLAY. RIGHT /LEFT ANGULATION KNOB PLAY. AIR/ WATER SOCKET CYLINDER O-RING CHIPPED. DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION. PASSED DRY LEAK TEST. ETO VENT VALVE LOOSE INNER SHAFT. SEGMENT STEEL BRAID CUT. PASSED WET LEAK TEST. ELEVATOR BODY SCREW LOOSE. FLUID INVASION NOT OBSERVED IN CONTROL BODY. FLUID INVASION NOT OBSERVED IN PVE CONNECTOR. PRISM LENS CHIPPED. LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE SCRATCHED. CUSTOMER COMPLAINT CONFIRMED. 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 RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO THE USER UPON COMPLETION. PARTS REPLACED: O-RINGS AND SEALS, AIR/WATER TUBE, OPERATION CHANNEL, ADJUSTING COLLAR, BENDING RUBBER, SEGMENT ATTACHING SCREW, DISTAL CASE ATTACHING SCREW, INSERTION FLEXIBLE TUBE, SEGMENT ASSY ATTACHING SCREW, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY IMP-C/PB-FREE, RL PULLEY ASSY, UD PULLEY ASSY, EOG VALVE ASSY, OBJECTIVE PRISM ASSY, DEFLECTOR BODY LINK, DISTAL CASE/CAP, O-RING(0.5X1.3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922043 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1