BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8841626 · Received July 30, 2019

    Report

    Report Number
    9610877-2019-01372
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 17, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON 17JUL2019 STATING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED- 3490TK, SERIAL NUMBER (B)(4), CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2019. THE SAMPLING PERFORMED ON 01JUL2019 IDENTIFIED 414 COLONY FORMING UNITS(CFU) AS COMPRISING OF THE FOLLOWING ISOLATE: 1 - POSITIVE COCCI - STAPHYLOCOCCUS HOMINIS, STUDY NUMBER: (B)(6). THE LONG TERM LOANER DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 16JUL2019. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 18JUL2019. INSPECTION FINDINGS INCLUDED THE FOLLOWING: IMAGE SPOTS, RIGHT ANGULATION DECREASED, DOWN ANGULATION INCREASED, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, DISTAL CAP/ CASE CRACKED, PASSED WET LEAK TEST, SUCTION TUBE RESISTANCE, PASSED DRY LEAK TEST, UMBILICAL CABLE BUMP UNDER PVE ROOT BRACE, UMBILICAL CABLE BUMP AT CONTROL BODY SIDE. REPAIRS WERE PERFORMED ON THE DUODENOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: SUCTION CHANNEL LG, O-RING(0.5X1.3), DISTAL CASE/CAP, O-RINGS AND SEALS, LCB DISTAL COVER. THE DUODENOSCOPE IS CURRENTLY PENDING RESAMPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636726 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1