BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8668474 · Received June 4, 2019

    Report

    Report Number
    9610877-2019-00328
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Report Date
    May 13, 2019
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX (B)(6) OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4)PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B(4). (B)(4). 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. EVENT PROBLEM AND EVALUATION CODES: (B)(4). METHOD: ACTUAL DEVICE EVALUATED; RESULT: WEAR PROBLEM. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    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 (ET-HF-P-0013 REV. 00). 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 10/MAY/2019, AND INSPECTION OF THE UNIT WAS PERFORMED ON 13/MAY/2019, WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION; FLUID INVASION IN PVE CONNECTOR; PRIMARY OPERATION CHANNEL RESISTANCE; AIR/ WATER SOCKET CYLINDER O-RING CHIPPED; PRISM SCRATCHED; SHIELD COVER CORRODED; PVE ELECTRICAL CONNECTOR FRAME HAS SEVERE CORROSION; ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - HI-POT; ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - PLCT; LIGHTGUIDE PRONG COVER GLASS SET LOOSE; IMAGE DISTORTED; INSERTION TUBE MILD SCRATCHES AT STAGE 1; FLUID INVASION NOT OBSERVED IN CONTROL BODY; HOLE IN # 2 REMOTE CONTROL BUTTON COVER; UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. 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 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 STAY COIL; OPERATION CHANNEL; BENDING RUBBER; LG CABLE CONNECTOR ASSY PB-FREE/NT; LIGHT GUIDE CABLE; SHIELD COVER; PCB FOR CCD K2 PB-FREE/NTSC; REMOTE CONTROL BUTTON; O-RINGS AND SEALS; DISTAL CASE/CAP; DEFLECTOR BODY LINK; DISTAL END W/CCD-M IMP-T PB-FREE/NT; BENDING RUBBER; LASER CUT FILTER TYPE 7; SHIELD PIPE FOR CCD. DURING REPAIRS, THE FOLLOWING WAS FOUND ON 30/MAY/2019, AND ADDRESSED DURING THE REPAIR PROCESS: CCD LASER FILTER LIFTING/ SMEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461218 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1