BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5172843 · Received October 24, 2015

    Report

    Report Number
    9610877-2015-00036
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    April 20, 2015
    Report Date
    August 14, 2018
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, PENTAX MEDICAL RECEIVED ADDTIONAL INFORMATION REGARDING THIS EVENT WHICH INCLUDED INFORMATION ABOUT THE PATIENT BEING RECALLED FOR SCREENING ON OR ABOUT (B)(6) 2015. THE RESULTS OF THE PATIENT SCREENING WERE NEGATIVE FOR CRE. IN ADDITION, FURTHER SCREENING WILL NOT BE PERFORMED ON THE PATIENT. PENTAX MEDICAL RECEIVED VIDEO DUODENOSCOPE MODEL ED-3490TK/SERIAL (B)(4) ON (B)(6) 2015. INCOMING INSPECTION DETECTED INSERTION TUBE BUBBLING, A CHIPPED LIGHT CARRYING BUNDLE DISTAL COVER GLASS, ZERO DEFLECTION ON UP/DOWN AND RIGHT/LEFT ANGULATION, RESISTANCE IN THE PRIMARY OPERATION CHANNEL, AND WORN SILICONE ON THE OBJECTIVE LENS. REPAIRS WERE NOT PERFORMED ON THE DUODENOSCOPE AS PENTAX MEDICAL SHIPPED THE DUODENOSCOPE TO THE MANUFACTURER ON (B)(6) 2015 FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    ON 9/28/2015, PENTAX MEDICAL WAS MADE AWARE OF A REPORT (MW5042669) THROUGH AN ON-LINE SEARCH OF THE FDA MAUDE DATABASE. THE INFORMATION PROVIDED IN THE DATABASE REFERENCED ERCP SCOPE MODEL ED-3490TK AND STATED, "AFTER APPROPRIATE CLEANING AND HIGH LEVEL DISINFECTION ROUTINE CULTURING ON THE DEVICE ELEVATOR PRODUCED A POSITIVE RESULT FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE). THIS PATIENT IS AT RISK FOR POTENTIAL EXPOSURE TO THE ORGANISM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704346 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1