BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENTAX

    MDR report key: 5104395 · Received September 25, 2015

    Report

    Report Number
    9610877-2015-00005
    Event Type
    Death
    Date Received
    September 25, 2015
    Report Date
    August 31, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CRE INFECTIONS ARISING OUT OF ALGH WERE THE SUBJECT OF MULTIPLE PREVIOUS MDRS AND RELATED INVESTIGATIONS; SEE 30-DAY MDR#'S 2518897-2013-00004, 2518897-2013-00005, 2518897-2013-00006, 2518897-2014-00001, AND 2518897-2014-00002 FILED ON (B)(6) 2013, (B)(6) 2014, RESPECTIVELY. ON (B)(6) 2015, PENTAX MEDICAL WAS NOTIFIED OF A LEGAL COMPLAINT REGARDING A PATIENT TREATED AT ADVOCATE LUTHERAN GENERAL HOSPITAL (ALGH), BUT INSUFFICIENT INFORMATION WAS PROVIDED AT THAT TIME TO IDENTIFY THE PATIENT OR MATCH THE PATIENT TO PATIENTS THAT WERE PREVIOUSLY THE SUBJECT OF THE REFERENCED MDRS. AS A RESULT, MDR 9610877-2015-00005 WAS FILED FOR THIS PATIENT WITH THE INFORMATION RECEIVED THROUGH THE LEGAL COMPLAINT. WITH THE RECEIPT OF THE ADDITIONAL INFORMATION ON 12/10/2015, PENTAX MEDICAL HAS BEEN ABLE TO CONFIRM THAT THIS PATIENT CORRESPONDS WITH A PATIENT PREVIOUSLY REPORTED IN A PRIOR MDR (MDR 2518897-2014-00001; (B)(6)). THEREFORE, GOING FORWARD PENTAX MEDICAL WILL CEASE SUPPLEMENTING MDR 2518897-2014-00001 AND WILL REPORT SUPPLEMENTAL INFORMATION ON THIS PATIENT EXCLUSIVELY TO THIS MDR. MDR 2518897-2014-00001 INCLUDES INFORMATION PREVIOUSLY REPORTED ON THE PATIENT IDENTIFIED IN THIS MDR ((B)(6)) AND ON THE DEVICE INVOLVED IN THE EVENT (VIDEO DUODENOSCOPE ED-3490TK/SERIAL (B)(4)).

    Description of Event or Problem · 1

    ON 31-AUG-2015, PENTAX MEDICAL WAS NOTIFIED OF A LEGAL COMPLAINT REGARDING A PATIENT TREATED AT (B)(6). THE LAWSUIT ALLEGES THAT THE DUODENOSCOPE (NOT SPECIFIED) USED ON THE PATIENT HAD BEEN CONTAMINATED WITH CARBAPENEM-RESISTANT ENTEROBACTERIOACEAE (CRE). THE COMPLAINT FURTHER ALLEGES THAT AFTER THE PROCEDURE PERFORMED ON OR ABOUT (B)(6) 2012, (B)(6) 2013, THE PATIENT DEVELOPED A CRE INFECTION AND DIED ON OR ABOUT (B)(6) 2013. PLAINTIFF'S ESTATE IS REPRESENTED BY COUNSEL. DUE TO THE FILING OF A LAWSUIT, PENTAX WILL SUPPLEMENT THIS MDR REPORT WITH ADDITIONAL INFORMATION AS IT IS RECEIVED THROUGH FORMAL DISCOVERY. CRE INFECTIONS ARISING OUT OF (B)(6) WERE THE SUBJECT OF MULTIPLE PREVIOUS MDRS AND RELATED INVESTIGATIONS; SEE 30-DAY MDR#'S 2518897-2013-00004, 2518897-2013-00005, 2518897-2013-00006, 2518897-2014-00001, 2518897-2014-00002, AND 2518897-2015-00024 FILED ON 09/20/2013, 10/28/2013, 11/12/2013, 03/06/2014, 03/06/2014, 07/24/2015 RESPECTIVELY. HOWEVER, THE PATIENT IDENTIFIED IN THE LAWSUIT COMPLAINT RECEIVED BY PENTAX CANNOT BE MATCHED TO PATIENTS THAT WERE PREVIOUSLY THE SUBJECT OF THE REFERENCED MDRS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PENTAX MEDICAL RECEIVED INFORMATION REGARDING THIS EVENT WHICH CONFIRMED AN (B)(6) FEMALE PATIENT UNDERWENT AN ERCP PROCEDURE WITH VIDEO DUODENOSCOPE MODEL ED-3490TK/SERIAL (B)(6) ON (B)(6) 2013 AND TESTED POSITIVE FOR CRE, BUT NO ACTIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635155 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death