BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 13444203 · Received February 3, 2022

    Report

    Report Number
    8010047-2022-02370
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 6, 2022
    Report Date
    March 17, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY HERE WAS A DIFFERENCE BETWEEN THE REPROCESS METHOD IMPLEMENTED BY THE FACILITY AND THE REPROCESS METHOD RECOMMENDED BY INSTRUCTIONS FOR USE (IFU). A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. AS STATED IN THE IFU: "IF THE SUCTION VALVE CLOGS AND THE SUCTION CANNOT BE USED WHEN SOLID MATTER, SUCH AS THE CLIP OR THICK FLUID, ARE ASPIRATED, WITHDRAW THE ENDOSCOPE AND DISCONNECT THE SUCTION TUBE FROM THE SUCTION CONNECTOR ON THE ENDOSCOPE CONNECTOR. ATTACH A SYRINGE CONTAINING STERILE WATER TO THE SUCTION CONNECTOR. STRAIGHTEN THE INSERTION TUBE AS MUCH AS POSSIBLE AND FORCEFULLY FLUSH THE CONNECTOR WITH THE WATER WHILE THE SUCTION VALVE OF THE ENDOSCOPE IS SLIGHTLY DEPRESSED. REPEAT THE FLUSH UNTIL THE THICK FLUID OR SOLID MATTER ARE DISCHARGED FROM THE DISTAL END OF THE SUCTION CHANNEL. AFTER DISCHARGING, CONFIRM THAT THERE IS NO IRREGULARITY IN THE SUCTION FUNCTION ACCORDING TO ¿INSPECTION OF THE SUCTION FUNCTION¿ ON PAGE 50, BEFORE USING THE ENDOSCOPE AGAIN. IF THE THICK FLUID OR SOLID MATTER CANNOT BE DISCHARGED, STOP USING THE SUCTION FUNCTION AND CONTACT OLYMPUS. FROM THE FOLLOWING DESCRIPTION IN THE IFU (OPERATION MANUAL), IT IS POSSIBLE TO DETECT THE PRESENCE OF A FOREIGN SUBSTANCE IN THE FORCEPS CHANNEL BEFORE THE CASE AND PREVENT THE EVENT. 3.8 INSPECTION OF THE ENDOSCOPIC SYSTEM: INSPECTION OF THE INSTRUMENT CHANNEL: 1 INSERT THE ENDOTHERAPY ACCESSORY THROUGH THE BIOPSY VALVE. CONFIRM THAT THE ENDOTHERAPY ACCESSORY EXTENDS SMOOTHLY FROM THE DISTAL END. ALSO MAKE SURE THAT NO FOREIGN OBJECTS COME OUT OF THE DISTAL END. 2 CONFIRM THAT THE ENDOTHERAPY ACCESSORY CAN BE WITHDRAWN SMOOTHLY FROM THE BIOPSY VALVE. THE REPROCESSING MANUAL: PRECLEANING THE ENDOSCOPE AND ACCESSORIES DESCRIBES THE IMPLEMENTATION OF PRECLEANING IMMEDIATELY AFTER THE CASE. 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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. THE SCOPE WAS INSPECTED, AND A CLEANING BRUSH WAS INSERTED INTO THE BIOPSY PORT. A HARD BLOCKAGE WAS NOTED AROUND 12 TO 15 CM INTO THE CHANNEL. THE BRUSH WAS INSERTED AGAIN FROM THE DISTAL END AND THE BLOCKAGE WAS DISLODGED. THE CHANNEL WAS BRUSHED AGAIN FROM THE BIOPSY PORT AND TWO PIECES OF LARGE DEBRIS (SEEDS OR NUTS) CAME OUT OF THE BIOPSY CHANNEL. NO OTHER DEBRIS WAS FOUND AND THE CHANNEL COULD THEN BE BRUSHED FREELY. THERE WERE CHIPS ON THE LIGHT GUIDE AND OPTICAL COVER GLASSES, WORN ADHESIVE ON THE LIGHT COVER GLASS, OPTICAL GLASS AND DISTAL END AND THE COLORED RING ON THE CONTROL BODY WAS WORN. THERE WAS PLAY ON THE UP/DOWN AND LEFT/RIGHT ANGLE CAUSING THE ANGLE TO NOT MEET SPECIFICATION. THE DEVICE DID NOT PASS THE WATER REMOVAL AND ELECTRICAL SAFETY INSPECTIONS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE INFORMATION OBTAINED FROM THE CUSTOMER AND APPLICABLE CORRECTIONS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE, FORCEPS WERE NOT ABLE TO BE PASSED THROUGH THE BIOPSY CHANNEL OF THE EVIS LUCERA ELITE COLONOVIDEOSCOPE. THE INSTRUMENT WAS INSPECTED BEFORE USE BUT THE CUSTOMER IS UNSURE IF ANYTHING WAS PASSED THROUGH THE BIOPSY CHANNEL OTHER THAN FLUID. THERE WAS NO DELAY TO THE PROCEDURE, HOWEVER, THE PROCEDURE WAS ABORTED AS IT WAS DETERMINED THAT NO BIOPSIES WERE REQUIRED AT THE TIME. THE PATIENT WAS NOT RESCHEDULED. THERE HAD BEEN A BACKUP DEVICE AVAILABLE AT THE TIME OF THE EVENT. DURING REPROCESSING, A CLEANING BRUSH WAS ALSO PREVENTED FROM PASSING THROUGH THE BIOPSY CHANNEL. INSPECTION OF THE RETURNED DEVICE FOUND A HARD BLOCKAGE IN THE CHANNEL THAT HAD BEEN ATTRIBUTED TO INSUFFICIENT CLEANING. IT IS UNKNOWN IF THIS EVENT WAS REPORTED TO THE LOCAL GOVERNING BODY BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED.

    Description of Event or Problem · 0

    ALTHOUGH THE CUSTOMER IS UNSURE IF THE PATIENT WAS SEDATED OR UNDER GENERAL ANESTHESIA WHEN THE PROCEDURE WAS ABORTED, THE CUSTOMER DOES NOT BELIEVE IT WAS LIKELY THAT THE PATIENT HAD BEEN. ADDITIONALLY, THE CUSTOMER DOES NOT KNOW IF THE PATIENT HAD BEEN TREATED FOR CROSS CONTAMINATION AS A RESULT OF THE SEEDS FOUND IN THE SCOPE BUT DOES NOT THINK THE PATIENT WAS. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451035 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FORCEPS.