BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 4944876 · Received July 24, 2015

    Report

    Report Number
    2518897-2015-00024
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    January 1, 2013
    Report Date
    May 8, 2015
    Manufacturer
    HOYA CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT OFFICE: (B)(4). DATE RECEIVED BY MFR: 04/11/2016. PMA/510(K)# K092710. FOLLOW UP #1. MFG DATE: 04/02/2009. (B)(4). THIS REPORT WAS SUBMITTED ON PAPER ON 05/9/2016 AND RECEIVED BY FDA ON 05/10/2016. ON 05/19/2016, PENTAX MEDICAL RECEIVED A LETTER FROM THE DIVISION DIRECTOR OF THE (B)(4) STATING THIS REPORT WAS NOT ACCEPTED DUE TO THE ELECTRONIC MEDICAL DEVICE REPORTING REQUIREMENT, IN EFFECT AS OF 08/14/2015. PRIOR TO BEING GRANTED THE REPORTING EXEMPTION IN AUGUST 2015, PENTAX MEDICAL WAS SUBMITTING REPORTS ON PAPER USING THE IMPORTER REPORT NUMBER AND COMPLETING ALL REQUIRED SECTIONS OF THE 3500A FORM. AFTER THE REPORTING EXEMPTION WAS GRANTED, PENTAX MEDICAL CONTACTED THE EXEMPTIONS COORDINATOR FROM THE (B)(4), OFFICE OF SURVEILLANCE & BIOMETRICS, DIVISION OF POSTMARKET SURVEILLANCE, MDR POLICY BRANCH, IN REGARDS TO SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY AN IMPORTER WAS SUBMITTED ON PAPER. ON 09/15/2015, A RESPONSE WAS RECEIVED FORM THE EXEMPTIONS COORDINATOR STATING PENTAX MEDICAL MAY CONTINUE TO SUBMIT SUPPLEMENTAL REPORTS ON PAPER USING THE SAME IMPORTER REGISTRATION NUMBER FROM THE ORIGINAL REPORT. PENTAX MEDICAL ADHERED TO THIS PROCESS. AFTER BEING NOTIFIED THAT THIS REPORT WAS NOT ACCEPTED BY FDA, PENTAX MEDICAL SPOKE TO THE EXEMPTIONS COORDINATOR VIA PHONE ON 05/20/2016, WHO STATED GOING FORWARD, WHEN SUBMITTING SUPPLEMENTAL REPORTS WHERE THE INITIAL REPORT FILED BY THE IMPORTER WAS SUBMITTED ON PAPER, ESUBMITTER SHOULD BE USED AND THE IMPORTER REPORT # SHOULD BE ENTERED. PENTAX MEDICAL CONTACTED THE EXEMPTIONS COORDINATOR ON 05/25/2016 SINCE IT WAS NOTICED THAT DATA ENTERED, DID NOT APPEAR ON THE PDF GENERATED BY ESUBMITTER. ON 05/25/2016, THE EXEMPTION COORDINATOR FORWARDED A MESSAGE FROM A STAFF MEMBER OF THE INFORMATION ANALYSIS BRANCH WHO WORKS ON IT ISSUES, WHO ALSO CONFIRMED THAT THE PDF GENERATED BY ESUBMITTER FOR AN IMPORTER REPORT DOES NOT REFLECT THE DATA. THE STAFF MEMBER INDICATED THIS WOULD NOT BE AN ISSUE SINCE THE XML FILE (SUBMITTED TO FDA AS PART OF THE ZIP FILE) GENERATED BY ESUBMITTER WILL DISPLAY INFORMATION ENTERED. THE EXEMPTIONS COORDINATOR CONFIRMED THE SAME ON 05/27/2016.

    Description of Event or Problem · 1

    ON APRIL 11, 2016, PENTAX MEDICAL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT. ON (B)(6) 2013, THE PATIENT HAD AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAM (ERCP) PROCEDURE AT (B)(4) USING VIDEO DUODENOSCOPE MODEL #ED-3490TK, SERIAL #(B)(4) AND VIDEO GASTROSCOPE MODEL EG-2990I, SERIAL #(B)(4). FROM (B)(6) 2014, THE PATIENT WAS ADMITTED TO (B)(6). DURING THIS ADMISSION, THE PATIENT HAD A (B)(4) DRAIN CULTURE POSITIVE FOR ESCHERICHIA COLI (METALLO BETA LACTAMASE PRODUCING ORGANISM); A BILIARY DRAIN CULTURE POSITIVE FOR ESCHERICHIA COLI (METALLO BETA LACTAMASE PRODUCING ORGANISM) AND FEW KLEBSIELLA PNEUMONIAE (CARBAPENEMASE PRODUCING ORGANISM); AND PELVIC DRAIN AND ABDOMINAL FLUID CULTURES POSITIVE FOR KLEBSIELLA PNEUMONIAE (CARBAPENEMASE PRODUCING ORGANISM). PATIENT WAS TREATED WITH ANTIBIOTICS (TIGECYCLINE, COLISTIN, AND MEROPENEM). FROM (B)(6) 2014, THE PATIENT WAS ADMITTED TO (B)(6). DURING THIS ADMISSION, THE PATIENT HAD LEFT RETRO HEPATIC HEMATOMA FLUID AND BILE DRAINAGE CULTURES POSITIVE FOR KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC). FROM (B)(6) 2014, THE PATIENT WAS ADMITTED TO (B)(6). DURING THIS ADMISSION, THE PATIENT HAD A BILE DRAINAGE CULTURE POSITIVE FOR KLEBSIELLA PNEUMONIAE (CARBAPENEMASE PRODUCING ORGANISM). BECAUSE TWO ENDOSCOPES WERE IDENTIFIED IN THE REPORT, A SECOND MDR IS BEING FILED FOR THE SAME PATIENT EVENT, BUT IT REFLECTS INFORMATION ON THE OTHER ENDOSCOPE. MDR 9610877-2016-00085 INCLUDES INFORMATION ON VIDEO GASTROSCOPE MODEL EG-2990I, SERIAL #(B)(4). MDR 2518897-2013-00004 INCLUDES INFORMATION PREVIOUSLY REPORTED ON THE DEVICE INVOLVED IN THE EVENT (VIDEO DUODENOSCOPE ED-3490TK/SERIAL (B)(4)).

    Description of Event or Problem · 1

    ON 05/08/2015, PENTAX MEDICAL WAS SERVED WITH A COMPLAINT (SUMMONS) FOR AN INJURY REGARDING A PATIENT TREATED AT (B)(6) HOSPITAL ((B)(6)). THE COMPLAINT 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) 2013, THE PATIENT DEVELOPED A CRE INFECTION. PATIENT IS REPRESENTED BY COUNSEL. DUE TO THE FILING OF A LAWSUIT, PENTAX WILL SUPPLEMENTAL 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 MDR'S AND RELATED INVESTIGATIONS; SEE 30-DAY MDR#'S 2518897-2013-00004, 2518897-2013-00005, 2518897-2015-00006, 2518897-2014-00001, AND 2518897-2014-00002 FILED ON 09/20/2013. 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. INITIALLY, IT WAS BELIEVED THIS PATIENT WAS COVERED BY A PREVIOUSLY SUBMITTED MDR (2518897-2013-00004). ON 06/30/2015, PENTAX MEDICAL BECAME AWARE OF THE NEED TO FILE A SEPARATE MDR BECAUSE IT WAS NOT CLEAR THAT THIS PATIENT WAS COVERED BY THE PREVIOUSLY SUBMITTED MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482418 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORP. ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R