BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTAX

    MDR report key: 5110474 · Received September 29, 2015

    Report

    Report Number
    9610877-2015-00004
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    July 6, 2014
    Report Date
    September 3, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION RELATED TO VIDEO DUODENOSCOPE MODEL ED-3490TK/(B)(4), INCLUDING EVENT PROBLEM AND EVALUATION CODES FOR THE DEVICE, WERE PREVIOUSLY REPORTED IN MDR# 2518897-2014-00001. THE PATIENT REFERENCED IN THIS MDR IS ALSO THE SAME PATIENT REFERENCED IN MDR 2518897-2015-00015. THIS MDR IS BEING SUBMITTED TO REFLECT A SEPARATE ERCP PROCEDURE PERFORMED ON THIS PATIENT ON (B)(6) 2013 WITH VIDEO DUODENOSCOPE MODEL ED-3490TK/(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT REFERENCED IN THIS MDR IS ALSO THE SAME PATIENT REFERENCED IN MDR 2518897-2015-00015.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PENTAX MEDICAL RECEIVED INFORMATION REGARDING THIS EVENT WHICH INDICATED THIS PATIENT UNDERWENT A PROCEDURE WITH VIDEO DUODENOSCOPE MODEL ED-3490TK/(B)(4) ON (B)(6) 2013.

    Description of Event or Problem · 1

    ON 12/18/2015, PENTAX MEDICAL RECEIVED ADDITIONAL INFORMATION REGARDING A THIS EVENT INCLUDING THE HOSPITALIZATIONS IDENTIFIED BELOW: HOSPITALIZATION AT (B)(6) HOSPITAL ((B)(6)). DURING THIS ADMISSION, THE PATIENT'S BLOOD CULTURES REVEALED ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE (CARBAPENENEMASE PRODUCING ORGANISM) AND KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC), NEGATIVE FOR METALLO BETA LACTAMASE (NDM). THE PATIENT WAS TREATED WITH ANTIBIOTICS TIGECYCLINE AND GENTAMICIN. HOSPITALIZATION AT (B)(6). DURING THIS ADMISSION, THE PATIENT HAD BLOOD AND URINE CULTURE RESULTS POSITIVE FOR ESCHERICHIA COLI. THE PATIENT WAS TREATED WITH CEFEPIME AND BACTRIM. HOSPITALIZATION AT (B)(6). DURING THIS ADMISSION THE PATIENT HAD A BLOOD CULTURE POSITIVE FOR ESCHERICHIA COLI. ON 12/18/2015, PENTAX MEDICAL RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT INCLUDING CAUSE OF DEATH. CAUSE OF DEATH IDENTIFIED ON THE DEATH CERTIFICATE: GALLBLADDER CARCINOMA AND SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640753 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H