BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS EVIS EXERA II GASTROVIDEOSCOPE

    MDR report key: 2588149 · Received May 22, 2012

    Report

    Report Number
    8010047-2012-00164
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 24, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED BY THE NURSE MANAGER THAT BASED ON THE PT'S RECORD THE PT DENIED PAIN UPON DISCHARGE FROM THE USER FACILITY. THE NURSE MGR FURTHER REPORTED THAT SHE DOES NOT ALLEGED THE SCOPE TO BE THE CAUSE OF THE PT'S OUTCOME, AS THE DEVICE HAS BEEN USED ON SUBSEQUENT PROCEDURES FOLLOWING THE PT'S PROCEDURE AND THERE WERE NO ISSUES REPORTED. THE SUBJECT DEVICE WAS SAID TO HAVE BEEN REPROCESSED IN AN OER-PRO AUTOMATED ENDOSCOPE PREPROCESSOR (AER). THE AER WAS EVALUATED BY OLYMPUS' FIELD SERVICE ENGINEER AND THERE WAS NO PROBLEM FOUND WITH THE MACHINE. THE SUBJECT GASTROSCOPE WAS NOT RETURNED TO OLYMPUS FOR EVAL, AS THE GASTROSCOPE IS WORKING APPROPRIATELY. THE PT IS REPORTEDLY DOING FINE. AS PART OF OUR INVESTIGATION INTO THIS MATTER, THE AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING IN-SERVICE IF NECESSARY. THE EXACT CAUSE OF THE PT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN EXCESS OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PT EXPERIENCED A SORE THROAT THE FOLLOWING DAY AFTER HAVING UNDERGONE A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE PT WAS CULTURED AND THE CULTURE WAS NEGATIVE. THE PT WAS SUBSEQUENTLY EXAMINED BY AN ENT PHYSICIAN, AND THE PHYSICIAN IDENTIFIED A CIRCULAR WHITE PLAQUE ON ONE SIDE OF THE PT'S THROAT. THE GI PHYSICIAN ALLEGED THAT MAY BE THE WHITE PLAQUE WAS DUE TO A CHEMICAL COLITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR