BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 3457417 · Received October 28, 2013

    Report

    Report Number
    2518897-2013-00005
    Event Type
    Injury
    Date Received
    October 28, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 30, 2013
    Manufacturer
    PENTAX OF AMERICA, INC.
    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

    ENDOSCOPE WAS EVALUATED BY USER AND BACTERIAL CULTURE (CRE) WAS FOUND BEHIND ELEVATOR. THE ACTUAL SCOPE HAS NOT YET BEEN EVALUATED BY PENTAX. INVESTIGATION IS STILL ONGOING. ADDITIONAL INFORMATION: TITLE IS MANAGER OF INFECTION CONTROL AND EPIDEMIOLOGY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, USER FACILITY REPORTED AN EVENT AS FOLLOWS: PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (DATE UNKNOWN) AND DEVELOPED A CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTION. THE PATIENT RECEIVED ANTIBIOTICS. NO FURTHER INFORMATION IS AVAILABLE AT THIS POINT ABOUT THE PATIENT. (B)(4) FOUND BEHIND ELEVATOR ON SCOPE. DURING A CONFERENCE CALL WITH ADVOCATE ON (B)(6) 2013 PENTAX WAS INFORMED THAT ONE PATIENT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTION AFTER UNDERGOING ERCP PROCEDURES USING SCOPE ED-3490TK, A110574. ADDITIONAL TWELVE PATIENTS WERE SCREENED FOR CRE; NINE PATIENTS SCREENED NEGATIVE AND 3 PATIENTS SCREENED POSITIVE FOR CRE BUT DID NOT DEVELOP A CRE INFECTION. THE SCOPE WAS TESTED AT THE USER FACILITY AND POSITIVE CULTURE WAS FOUND BEHIND THE ELEVATOR AND THROUGH THE HOLE OF THE SCOPE. CUSTOMER CONFIRMED THAT NON-PENTAX BRUSHES ARE USED TO MANUALLY REPROCESS THE PENTAX SCOPES. THE CLEANING BRUSHES USED AT THE FACILITY ARE MEDIVATORS. IN ADDITION, SURG-ENZ IS THE ENZYMATIC DETERGENT/CLEANER USED TO REPROCESS THE SCOPES AND IS NOT ON THE PENTAX APPROVED LIST OF DETERGENTS. CIDEX OPA IS USED FOR HIGH LEVEL DISINFECTION. ACCORDING TO THE PENTAX REPROCESSING/MAINTENANCE INSTRUCTION FOR USE (IFU), IT SPECIFICALLY STATES THAT USER MUST "BE AWARE THAT ALL RECESSED AREAS AROUND THE ELEVATOR MECHANISM SHOULD BE THOROUGHLY CLEANED WITH AN APPROPRIATELY SIZED CYLINDER CLEANING BRUSH (E.G. CSC9S) AND IN A CLEANING DETERGENT SOLUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551346 PENTAX VIDEO DUODENOSCOPE FDT PENTAX OF AMERICA, INC. ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R