BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 12674521 · Received October 21, 2021

    Report

    Report Number
    8010047-2021-13503
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 30, 2021
    Report Date
    December 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED AS RESTRICTION WAS FOUND DURING INSPECTION AND TESTING BUT THE CAUSE OF THE RESTRICTION WAS UNKNOWN. ADDITIONALLY, THE SCOPE FAILED THE LEAK TEST FROM THE INSTRUMENT CHANNEL (NO FLUID INVASION NOTED). SWITCH BUTTON NUMBER ONE HAS A CUT. THERE ARE DEEP SCRATCHES ON THE DISTAL END COVER. THE TWO LIGHT GUIDE LENSES AT THE DISTAL END ARE CRACKED. THE BENDING SECTION COVER GLUE IS CRACKED AND DISCOLORED. ALSO, THE UP/DOWN CONTROL KNOB HAS PLAY, THE GLUE AT THE DISTAL END OBJECTIVE LENS IS PEELING/CRACKED AND THE LIGHT GUIDE TUBE HAS BUCKLES AND MINOR SCRATCHES. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE/MALFUNCTION CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE USER FACILITY REGARDING THE REPORTED EVENT. THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE BRUSH PASSAGE THROUGH THE BIOPSY CHANNEL FELT TIGHT DUE TO FOREIGN MATERIAL IN THE CHANNEL. THIS IS LIKELY DUE TO THE THE FACILITY STAFF LESS TRAINED ON REPROCESSING AND/OR DEVICE HANDLING ACCORDING TO IFU, WHICH MADE FOREIGN MATERIAL REMAIN INSIDE THE BIOPSY CHANNEL. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): REPROCESSING MANUAL SAYS ABOUT INSUFFICIENT REPROCESSING AS BELOW: 1.4 PRECAUTIONS: WARNING: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ TO PREVENT DIRT FROM ADHERING, IFU (REPROCESSING MANUAL) SAYS USER TO PRECLEAN DEVICES IMMEDIATELY AFTER EACH PROCEDURE IN ¿PRECLEANING THE ENDOSCOPE AND ACCESSORIES¿ AS BELOW: ¿IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IN THE PATIENT PROCEDURE ROOM IMMEDIATELY AFTER EACH PATIENT PROCEDURE.¿ OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE SERVICE CENTER WAS INFORMED THAT WHEN THE CUSTOMER RUNS A BRUSH THROUGH IT (EVIS EXERA III COLONO-VIDEOSCOPE) DURING REPROCESSING THE BRUSH CAN GET THROUGH BUT IT IS TIGHT. THE CHANNEL PORT HAS AN OBSTRUCTION; A BORESCOPE WAS USED AND A FOREIGN OBJECT CAN BE SEEN. THE CUSTOMER CANNOT GET IT OUT AND THE SCOPE WILL BE RETURNED FOR SERVICE. NO PATIENT INJURY OR HARM WAS REPORTED.

    Description of Event or Problem · 0

    THE LEAD CENTRAL STERILE PROCESSING DEPARTMENT TECHNICIAN FURTHER REPORTED THAT THE FACILITY'S BORESCOPE WAS USED TO INSPECT INSIDE THE SCOPE'S CHANNELS BUT COULD NOT VISUALLY SEE ANY FOREIGN OBJECT OR MATERIAL INSIDE THE CHANNEL. HOWEVER, THERE WAS RESTRICTION AND IT COULD NOT DETERMINE WHAT WAS CAUSING THE RESTRICTION SO THE FACILITY WANTED TO SEND IT IN FOR REPAIR EVALUATION TO BE SURE THERE WAS NOTHING STUCK INSIDE. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574505 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown