BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II GI VIDEOSCOPE

    MDR report key: 2835386 · Received November 6, 2012

    Report

    Report Number
    8010047-2012-00425
    Event Type
    Other
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 16, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY. ON (B)(6) 2012, PATIENT #3 HAD AN UPPER GI ENDOSCOPY. ON (B)(6) 2012, THE PATIENT HAD SEVERE THROAT PAIN LEVEL = 8 (PAIN SCALE 0-10), CHILLS, FELT FEVERISH (HAD NO THERMOMETER AT HOME) AND LOSS OF VOICE. HE WAS SEEN AT A MINOR EMERGENCY CENTER AND WAS DIAGNOSED WITH A THROAT INFECTION BUT TESTED NEGATIVE FOR STREP THROAT. HE WAS PLACED ON ANTIBIOTICS. ON (B)(6) 2012, HIS SYMPTOMS WERE RESOLVING. AN ESS WAS DISPATCHED TO THE USER FACILITY TO INVESTIGATE AND REVIEW SCOPE HANDLING, REPROCESSING AND MAINTENANCE. A NUMBER OF REPROCESSING INCONSISTENCIES WERE NOTED. ON THE SECOND VISIT, THE OBSERVATIONS FROM THE PRIOR VISIT WERE DISCUSSED AND A REPROCESSING IN-SERVICE WAS PERFORMED. THE USER FACILITY HAS IMPLEMENTED ALL OLYMPUS REPROCESSING RECOMMENDATIONS HENCE. THIS IS ONE OF SEVEN REPORTS. PLEASE ALSO REFERENCE 8010047-2012-00423, 00424, 00426, 00427, 00428, 00429. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS NOTIFIED THAT SEVEN PATIENTS HAVE HAD FEVERS FOLLOWING ENDOSCOPIC PROCEDURES. WITHIN THE LAST MONTH THE FACILITY HAD SWITCHED FROM ALL PENTAX ENDOSCOPES TO OLYMPUS ENDOSCOPES. AFTER THE SWITCH, A COMPLETE REPROCESSING IN-SERVICE WAS PERFORMED BY AN OLYMPUS ENDOSCOPY SERVICE SPECIALIST (ESS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II GI VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other MOLONEY DILATOR