BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10858044 · Received November 17, 2020

    Report

    Report Number
    8010047-2020-09063
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 20, 2020
    Report Date
    January 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS AUSTRALIA & NEW ZEALAND (OAZ). THE EVALUATION OF THE DEVICE BY OAZ CONFIRMED THE FOLLOWING; OAZ COULD NOT CONFIRM THE OCCURRENCE OF THE REPORTED EVENT AND THERE WAS NO FOREIGN MATERIAL IN THE CHANNEL OF THE DEVICE. THE AIR / WATER FLOW AND VOLUME WERE WITHIN SPECIFICATIONS. FROM ADDITIONAL INFORMATION BY THE USER FACILITY, OMSC CONFIRMED THE FOLLOWING; THE REPORTED EVENT OCCURRED DURING GASTROSCOPY AND POLYPECTOMY AND WAS COMPLETED AFTER DEVICE REPLACEMENT. WHEN THE USER PUSHED THE INSTRUMENT, A FOREIGN MATERIAL EXITED FROM THE DISTAL END. IT IS UNKNOWN FROM WHICH CHANNEL OF THE DEVICE THE FOREIGN MATERIAL EXITED. THE FOREIGN MATERIAL FELL INTO THE PATIENT'S BODY, BUT WAS SUBSEQUENTLY RECOVERED BY THE USER. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE PROPERTIES OF THE FOREIGN MATERIAL. BASED ON THE INFORMATION THAT THE REPORTED EVENT OCCURRED WHEN THE INSTRUMENT WAS PUSHED IN, OMSC CONCLUDED THAT THE FOREIGN MATERIAL MAY HAVE EXITED FROM THE INSTRUMENT CHANNEL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THE REPORTED EVENT WAS CAUSED BY CUSTOMER HANDLING, REPROCESSING, OR THE ENDOTHERAPY ACCESSORIES USED. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A PROCEDURE, FOREIGN MATERIAL EXITED FROM THE CHANNEL OF THE DEVICE. AND THE FOREIGN MATERIAL WAS PATHOLOGICALLY TESTED BUT COULD NOT BE IDENTIFIED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314873 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1