BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9096853 · Received September 20, 2019

    Report

    Report Number
    9610877-2018-00417
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Report Date
    September 11, 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
    MD, US
    Reporter Occupation
    003

    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 21SEP2018, 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 07/SEP/2018 AND INSPECTION OF THE UNIT WAS PERFORMED ON 11/SEP/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: EQUIPMENT SERVICED BY NON-PENTAX FACILITY, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, BENDING RUBBER NON-PENTAX MATERIAL, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, INSERTION TUBE NON-PENTAX MATERIAL, PRIMARY OPERATION CHANNEL NON-PENTAX MATERIAL, PRIMARY OPERATION CHANNEL RESISTANCE, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, # 2 REMOTE CONTROL BUTTON COVER CRACKED, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, CUSTOMER COMPLAINT CONFIRMED, INSERTION TUBE ROOT BRACE BROKEN, RUBBER TRIM COLLAR SEVERE CUT. INSPECTION OF THE SEAL BETWEEN THE DISTAL BODY AND DISTAL CAP WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892148 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1