BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 3491026 · Received November 12, 2013

    Report

    Report Number
    2518897-2013-00006
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    June 30, 2013
    Report Date
    October 18, 2013
    Manufacturer
    PENTAX OF AMERICA, INC.
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A CONFERENCE CALL WITH ADVOCATE (B)(6) GENERAL HOSPITAL ON (B)(6) 2013, PENTAX WAS INFORMED THAT ONE PT DEVELOPED CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTION AFTER UNDERGOING ERCP PROCEDURES USING SCOPE ED-3490TK, (B)(4). IN ADDITION, ONE PT WAS SCREENED FOR CRE BUT DID NOT DEVELOP AN 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. METRICIDE 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." 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 (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, USER FACILITY REPORTED AN EVENT AS FOLLOWS: PT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (DATE UNKNOWN) AND DEVELOPED AN CARBAPENEM-RESISTANT ENTEROBACTERIACEAE (CRE) INFECTION. THE PT RECEIVED ANTIBIOTICS AND WAS RELEASED FROM THE HOSPITAL ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS POINT ABOUT THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584163 PENTAX VIDEO DUDODENOSCOPE FDT PENTAX OF AMERICA, INC. ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R