BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9305112 · Received November 11, 2019

    Report

    Report Number
    9610877-2019-01548
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 30, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K161222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON (B)(6) 2019 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 (B)(6) 2019 IDENTIFIED 420 COLONY FORMING UNITS(CFU) AS COMPRISING OF THE FOLLOWING 2 ISOLATES: POSITIVE COCCI - STAPHYLOCOCCUS AUREUS, POSITIVE RODS - CORYNEBACTERIUM SIMULANS. STUDY NUMBER: 1222631. THE LONG TERM LOANER DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 09-OCT-2019. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 15-OCT-2019 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: DISTAL CAP/ CASE CRACKED, RIGHT /LEFT ANGULATION KNOB PLAY, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, UP/ DOWN ANGULATION KNOB PLAY, PASSED WET LEAK TEST, SUCTION TUBE RESISTANCE, PASSED DRY LEAK TEST, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, LCB DISTAL COVER GLASS MIDDLE PIN HOLE IN GLUE. AN ADDITIONAL EVALUATION PERFORMED ON 07-NOV-2019 NOTED THE FOLLOWING: PRIMARY OPERATION CHANNEL EXCESS GLUE AT DISTAL END, RIGHT/ LEFT BRAKE KNOB LOOSE. THE DUODENOSCOPE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, SUCTION CHANNEL LG, LCB DISTAL COVER. PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 06-JAN-2016. THE VIDEO DUODENOSCOPE IS CURRENTLY AWAITING QC FINAL APPROVAL AND CULTURE RESAMPLING AS OF 11-NOV-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099238 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1