BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 6052886 · Received October 24, 2016

    Report

    Report Number
    2951238-2016-00814
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    August 16, 2016
    Report Date
    November 21, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS RECEIVED NEW INFORMATION FROM THE USER FACILITY INDICATING THAT THE PATIENT WAS NOT CULTURED AND THE EVENT DATE WAS ON (B)(6) 2016. THE USER FACILITY REPORTED THAT THEY UTILIZED A MEDIVATOR DSD, SERIAL NUMBER (B)(4) AER TO REPROCESS THEIR SCOPES.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED THE DEVICE TO OLYMPUS FOR EVALUATION. THE EVALUATION NOTED A LEAK AT THE DISTAL END OF THE DEVICE. THE BENDING SECTION WAS INSPECTED AND FOUND BROKEN STRANDS (MESH WIRES) AND MULTIPLE INDENTS ALONG THE BENDING MESH. FURTHER INSPECTION FOUND THE BENDING SECTION COVER GLUE TO BE CRACKED WITH EVIDENCE OF CHEMICAL DAMAGE. . THE LIGHT GUIDE LENS WAS ALSO NOTED TO BE CRACKED. A BORESCOPE WAS USED TO EXAMINE THE INTERNAL CHANNEL OF THE DEVICE AND FOUND SCRAPE MARKS. AS PART OF OUR INVESTIGATION ON OCTOBER 5, 2016 AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS AND OBSERVE THE USER FACILITY¿S REPROCESSING PRACTICES. THE ESS NOTED THE FOLLOWING DEVIATIONS DURING THE ONSITE OBSERVATIONS: THE BRUSHING OF THE SUCTION AND INSTRUMENT CHANNEL WAS PERFORMED OUT OF ORDER FOR THE CHANNEL CLEANING BRUSH AND CHANNEL OPENING BRUSH. THE CHANNEL OPENING BRUSH WAS USED PRIOR TO THE CHANNEL CLEANING BRUSH. THIS WOULD ALLOW MATERIAL TO BE MISSED AFTER REMOVAL OF THE CHANNEL CLEANING BRUSH DUE TO THE SIZE OF THE OPENING IN THE SUCTION CYLINDER WITH RELATION TO THE CHANNEL OR BRUSH SIZE. TWO OF THE FIVE TECHNICIANS WERE USING A CHANNEL PULL THROUGH BRUSH WHICH IS NOT DOCUMENTED IN THE IFU. THIS PRACTICE INCLUDES INSERTION OF A CHANNEL CLEANING BRUSH INTO THE SUCTION CYLINDER OPENING REMOVING THE BRUSH THROUGH THE DISTAL END OR SUCTION PORT ON THE SCOPE CONNECTOR. THE GROOVES ALONG THE C-BODY AND V GROOVE ON THE RISER WERE MISSED DURING CLEANING. THE DUODENOSCOPE WAS NOT REMOVED FROM THE WATER PRIOR TO PRESSURE RELEASE AND DETACHMENT OF THE DUODENOSCOPE FROM THE LEAK TEST CABLE. AS A RESULT OF THE IN-SERVICE A REVIEW WAS CONDUCTED WITH CORRECTIVE DISCUSSION AND DEMONSTRATION WAS PERFORMED TO ENSURE THE TECHNICIANS WERE INFORMED OF THE CORRECT PROCESS. OLYMPUS CANNOT DETERMINE THE CAUSE OF THE REPORTED EVENT, BUT THE CONDITION OF THE RETURNED DUODENOVIDEOSCOPE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. ENDOSCOPES THAT FAIL LEAK TESTING CAN POSE AN INFECTION CONTROL RISK. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT SEVERE EQUIPMENT DAMAGE AND PATIENT INJURY: ¿PERFORM A LEAKAGE TEST ON THE ENDOSCOPE AFTER EACH PRE-CLEANING PROCEDURE. DO NOT USE THE ENDOSCOPE IF A LEAK IS DETECTED. USE OF AN ENDOSCOPE WITH A LEAK MAY CAUSE A SUDDEN LOSS OF THE ENDOSCOPIC IMAGE, DAMAGE TO THE BENDING MECHANISM, OR OTHER MALFUNCTIONS. USE OF A LEAKING ENDOSCOPE MAY ALSO POSE AN INFECTION CONTROL RISK.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PATIENT DEVELOPED A SERRATIA MARCESCENS BLOODSTREAM INFECTION ONE DAY POST AN ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT REMOVAL. IT IS UNKNOWN IF THE PATIENT WAS HOSPITALIZED OR RECEIVED MEDICAL TREATMENT FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703619 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other