BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II BRONCHOVIDEOSCOPE

    MDR report key: 4101722 · Received August 28, 2014

    Report

    Report Number
    2951238-2014-00418
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K050220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. HOWEVER, REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS PURCHASED ON (B)(6)2013, BUT THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR SERVICE SINCE THEN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTAL. PLEASE REFERENCE THE ASSOCIATES DEVICES, SEE MFR REPORTS: 2951238-2014-400, 401,402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 419, 420, 421.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE IN-SERVICE VISITS PROVIDED BY THE ENDOSCOPY SUPPORT SPECIALIST (ESS) ON AUGUST 21, 2014 AND OCTOBER 3, 2014. THE ESS VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES. DURING THE IN-SERVICE VISIT IT WAS OBSERVED THAT THE ENDOSCOPES WERE BEING HUNG WITH PEEL PACK COVERS (DISTAL TIP PROTECTORS) OVER THE INSERTION TUBES WHILE DRYING. AS PART OF EDUCATING THE CUSTOMER, A COPY OF THE DISTAL TIP PROTECTOR LETTER FROM INFECTION CONTROL WAS PROVIDED TO THE USER FACILITY AS WELL AS BOTH MANUALS ON THE PROPER CLEANING AND REPROCESSING OF THE 180 SERIES BRONCHOSCOPES AND COLONOSCOPES. IT WAS ALSO REPORTED THAT NO OTHER REPROCESSING DEVIATIONS WERE FOUND DURING THE ON-SITE VISIT. OLYMPUS DOES NOT RECOMMEND NOR ENDORSE THE USE OF THE DISTAL TIP PROTECTORS DURING STORAGE. IT WAS NOTED THAT THE ENDOSCOPE DISTAL TIP PROTECTORS ARE NOT TO BE REPROCESSED OR REUSED. REUSE COULD PRESENT AN INFECTION CONTROL RISK IF THE DISTAL END PROTECTORS CANNOT BE THOROUGHLY DRIED. ADDITIONALLY, THE ATTACHMENT OF A NON-STERILE DISTAL TIP PROTECTOR TO THE ENDOSCOPE WHICH HAS BEEN HIGH-LEVEL DISINFECTED OR STERILIZED MAY CAUSE RECONTAMINATION OF THE ENDOSCOPE. OLYMPUS BRONCHOSCOPE INSTRUCTION MANUAL ADVISES USERS: "STORAGE OF ENDOSCOPE: TO HANG THE ENDOSCOPE IN THE STORAGE CABINET WITH THE DISTAL END HANGING FREELY." IF ADDITIONAL OR SIGNIFICANT INFORMATION IS AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    POSITIVE FOR E. COLI AND PSEUDOMONAS AERUGINOSA, AND CANDIA AFTER UNDERGOING A BRONCHOSCOPY PROCEDURE FROM APRIL 2014 TO JUNE 2014. ALL THE PATIENTS WERE REPORTED TO HAVE BEEN EXAMINED USING THE SAME DEVICE BUT BY DIFFERENT PHYSICIANS. THE USER FACILITY CONDUCTED TWO SETS OF CULTURE TEST ON THE O-RING OF THE DEVICE USING THEIR IN-HOUSE LABORATORY AND AN INDEPENDENT LABORATORY. BOTH CULTURE TESTS WERE POSITIVE FOR MICRO-ORGANISMS. MANY OF THE PATIENTS THAT TESTED POSITIVE FOR THE AFOREMENTIONED MICRO-ORGANISMS HAD PRE-EXISTING RESPIRATORY PROBLEMS. THE TREATMENT PROVIDED TO THE PATIENTS VARIED BUT MANY RECEIVED IV ANTIBIOTICS. ALL PATIENTS HAVE FULLY RECOVERED AND HAVE BEEN CLEARED OF THE SUSPECTED INFECTIONS. THE USER FACILITY HAS REMOVED THE DEVICE FROM USE AS OF(B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526494 EVIS EXERA II BRONCHOVIDEOSCOPE BRONCHOSCOPE EOQ OLYMPUS MEDICAL SYSTEM CORP. BF-1T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other