BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9031506 · Received September 13, 2019

    Report

    Report Number
    9610877-2018-00576
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    August 8, 2017
    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). 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 14DEC2018, 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 DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 03/AUG/2017 AND INSPECTION OF THE UNIT WAS PERFORMED ON 08/AUG/2017 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: BENDING RUBBER PINHOLE, FAILED WET LEAK TEST, SEGMENT STEEL BRAID CUT, SEGMENT STEEL BRAID LOOSE, FAILED DRY LEAK TEST, DISTAL CAP MISSING SILICONE, INSERTION TUBE MILD DISCOLORATION AT STAGE 2, INSERTION TUBE MILD DISCOLORATION AT STAGE 1, 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 INCLUDES THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO THE USER ON (B)(6) 2017. PARTS REPLACED: O-RINGS AND SEALS, BENDING RUBBER, DISTAL CASE/CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818497 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1