BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX VIDEO DUODENOSCOPE

    MDR report key: 4301576 · Received March 7, 2014

    Report

    Report Number
    2518897-2014-00001
    Event Type
    Injury
    Date Received
    March 7, 2014
    Report Date
    March 6, 2014
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS ((B)(6) 2013) REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). ADDITIONAL INFO FROM THE FACILITY REVEALED EIGHT (8) MORE PTS TESTING POSITIVE FOR CRE, BUT HAD NOT DEVELOPED AN ACTIVE INFECTION. THESE PTS WERE THREE (3) FEMALES ((B)(6)) AND THREE (3) MALES ((B)(6)). THESE CASES ARE BEING REPORTED AS THEY ARE SURVEILLANCE CULTURE POSITIVE CASES. THERE WAS NO FURTHER INFO PROVIDED BY THE FACILITY. THIS IS 1 OF 7 REPORTS.

    Additional Manufacturer Narrative · 2

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 2

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PATIENT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PATIENT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) , BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIA CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL); NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 7 OF 7 REPORTS.

    Additional Manufacturer Narrative · 3

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 3

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 6 OF 7 REPORTS.

    Additional Manufacturer Narrative · 4

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 4

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 5 OF 7 REPORTS.

    Additional Manufacturer Narrative · 5

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 5

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 4 OF 7 REPORTS.

    Additional Manufacturer Narrative · 6

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 6

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 3 OF 7 REPORTS.

    Additional Manufacturer Narrative · 7

    PENTAX MEDICAL WAS ONLY RECENTLY ((B)(4) 2014) MADE AWARE OF PTS WITH CRE ORGANISM AFTER UNDERGOING ERCP PROCEDURE WITH SCOPE (SERIAL NUMBER (B)(4)), THE SCOPE WAS SOLD TO (B)(6) ON (B)(4) 2013. THE SCOPE IS CURRENTLY IN USE AT THE HOSPITAL. PER E-MAIL FROM HOSPITAL ON (B)(4) 2014, THE SCOPE HAD TESTED NEGATIVE (TEST DATE UNK) FOR CRE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THERE WERE NO REPORTS OF ANY NON-CONFORMANCE ISSUES DURING THE MFG IN-PROCESS AND FINAL INSPECTION. THE DEVICE WAS MFG ACCORDING TO SPECS. SUBJECT DEVICE COULD NOT BE EVALUATED AS IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 7

    IT WAS REPORTED BY FACILITY ON (B)(4) 2014; PT HAD UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2013 AND WAS TESTED FOR CRE. TEST RESULTS REVEALED PT TESTED POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE), BUT HAD NOT DEVELOPED AN ACTIVE CRE INFECTION E.G., KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC); METALLO-B-LACTAMASES (MBL): NEW DELHI MBL (NDM); AND VERONA INTEGRON-ENCODED MBL (VIM). THIS IS 2 OF 7 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140668 PENTAX VIDEO DUODENOSCOPE PENTAX VIDEO DUODENOSCOPE FDT PENTAX MEDICAL COMPANY ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other
    2 81 YR
    3 78 YR Other
    4 67 YR Other
    5 85 YR Other
    6 82 YR Other
    7 81 YR Other