BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5000689 · Received August 11, 2015

    Report

    Report Number
    2518897-2015-00029
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    January 1, 2015
    Report Date
    July 20, 2015
    Manufacturer
    HOYA CORPORATION
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT ON 07/20/2015 STATING "POST ERCP BACTEREMIAS WITH CTX RE COLI WHICH HAS BEEN ASSOCIATED WITH 3 PATIENT SINCE JANUARY." THE DUODENOSCOPE INVOLVED AT PENTAX MEDICAL ON (B)(6) 2015 TO REPAIR A REPORTED LEAK AND IS CURRENTLY ON HOLD PENDING FURTHER EVALUATION. GOOD FAITH ATTEMPTS WERE MADE VIA E-MAIL ON 07/23/2015 AND 07/30/2015 TO THE FACILITY TO CONFIRM DETAILS OF THE EVENT, AND TO OBTAIN A FACILITY CONTACT TO RECEIVE INFORMATION ON THE 3 PATIENTS. NO INFORMATION HAS BEEN RECEIVED FROM THE FACILITY TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525350 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention