BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 6084540 · Received November 7, 2016

    Report

    Report Number
    2951238-2016-00839
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE DEVICE WAS PURCHASED ON OCTOBER 21, 2013 AND WAS LAST SERVICED AT OLYMPUS ON AUGUST 23, 2016. OLYMPUS MADE MULTIPLE FOLLOW UPS WITH THE USER FACILITY BY TELEPHONE AND IN WRITING IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION ON THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDF TO FDS AND 510(K) NUMBER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AFTER AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE (DATE OF PROCEDURE UNKNOWN), THE PATIENT REPORTEDLY SUSTAINED BURN MARKS ON THE TONGUE AND MOUTH. IT IS UNKNOWN IF THE PATIENT WAS PROVIDED MEDICAL OR SURGICAL INTERVENTION. IT WAS ALSO REPORTED THAT DURING THE CASE, THE VIDEO IMAGE WAS DISTORTED. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732626 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ190 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other