EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00590
- Event Type
- Malfunction
- Date Received
- October 1, 2018
- Report Date
- August 13, 2019
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDT
- PMA / PMN Number
- K024033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT. ALSO, TO UPDATE THIS INFORMATION IN THE CORRECT FIELD.
THE OEM REPORTED THAT THE SUMMARY OF THE INVESTIGATION FINDINGS ARE AS FOLLOWS: THE ORGANISMS DETECTED WERE OF INTESTINAL FLORA AND THE NUMBER OF COLONIES WAS POTENTIALLY HIGH.1 OTHER LOW CONCERN MICROORGANISMS WERE DETECTED. SEVERAL DEVIATIONS IN THE SAMPLING PROCEDURES WERE OBSERVED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THIS PHENOMENON WAS POSSIBLY OCCURRED DUE TO FOLLOWING: IT WAS NOT POSSIBLE TO CONDUCT SEVERAL INVESTIGATIONS AT THIS SITE, YIELDING LITTLE INFORMATION TO DETERMINE A ROOT CAUSE. PROBABLY CONTAMINATION DUE TO INSUFFICIENT REPROCESSING BECAUSE OF THE OCCURRENCE OF ENTEROCOCCUS DURANS AND HIGH NUMBER OF COLONIES WITH OTHER LOW CONCERN ORGANISMS. WHILE INADEQUATE SAMPLING IS PROBABLY NOT THE PRIMARY CAUSE, IT CANNOT BE COMPLETELY RULED OUT DUE TO THE DEVIATIONS OBSERVED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). PLEASE SEE THE UPDATES TO SECTIONS: G4, G7, H2 AND H10. THE SCOPE¿S SUCTION AND CHANNEL WERE SENT THE OEM FOR FURTHER INVESTIGATION. THE OEM REPORTED THAT TWO OBSERVED RESIDUE SPOTS ADHERING TO THE INSIDE OF THE RECEIVED CHANNEL WERE ANALYZED. THE RESIDUE SPOTS WERE LABELED AS SAMPLE O AND SAMPLE P. ·SAMPLE O: FLAT UNCLEAR GOLD SUBSTANCES WHICH APPEAR TO BE A METAL PIECE ·SAMPLE P: DRIED ROUND GRANULAR BROWNISH SUBSTANCES WHICH BECAME POWDERED BY BEING PRESSED PLEASE SEE THE ANALYSIS RESULTS BELOW. ¿SAMPLE O¿ «ANALYSIS RESULTS» FT-IR CHART: FT-IR WAS NOT PERFORMED BECAUSE THIS SAMPLE WAS CLEARLY METAL. EDX CHART: CU WAS CLEARLY DETECTED. ALSO, ZN, C, FE, PB, O AND SI WERE DETECTED. BRASS IS THOUGHT TO BE A MAJOR ELEMENT OF SAMPLE O BECAUSE ZN, C, FE, PB, O AND SI WERE DETECTED BY EDX. FROM THESE ANALYSIS RESULTS, A MAJOR ELEMENT IS THOUGHT TO BE BRASS, AND FE, SI AND OTHER ELEMENTS WERE ALSO CONTAINED. «THE EVALUATION RESULT OF BIOLOGICAL ORIGIN» SAMPLE O CANNOT BE IDENTIFIED AS BIOLOGICAL ORIGIN-SUBSTANCE BECAUSE NO PROTEIN WAS DETECTED. ¿SAMPLE P¿ «ANALYSIS RESULTS» FT-IR CHART: : WE CAN FIND PEAKS SHOWING PRESENCE OF FATTY ACID SALTS, TALC AND SILICONE AND PEAKS SHOWING PRESENCE OF FLUORINE COMPOUND(PTFE) WHICH IS CONTAINED IN OF CHANNEL MATERIALS. EDX CHART: C, O, N AND F WERE CLEARLY DETECTED. ALSO, FE, B AND SI WERE DETECTED. SAMPLE P IS THOUGHT TO CONTAIN IRON RUST FOR FOLLOWING REASONS; FT-IR SHOWS PRESENCE OF FATTY ACID SALTS. EDX DETECTED FE IN ADDITION TO C AND O. THE COLOR OF SAMPLE P IS BROWNISH. FROM THESE ANALYSIS RESULTS, SAMPLE P IS THOUGHT TO BE A MIXTURE OF IRON RUST, SILICONE AND TALC. «THE EVALUATION RESULT OF BIOLOGICAL ORIGIN» SAMPLE P CANNOT BE IDENTIFIED AS BIOLOGICAL ORIGIN-SUBSTANCE BECAUSE NO PROTEIN WAS DETECTED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INDEPENDENT LABORATORY RESULTS AND TO PROVIDE THE EVALUATION FINDINGS. AS PART OF THE PMS STUDY INVESTIGATION, AN OLYMPUS ENGINEER WAS DISPATCHED TO THE USER FACILITY TO OBSERVE THE SCOPE SAMPLER¿S TECHNIQUE. THE ENGINEER REPORTED THAT THE SAMPLER DID NOT USE THE APPROPRIATE ASEPTIC TECHNIQUE, WHILE OBTAINING A SAMPLE FROM THE SCOPE. THE ENGINEER PERFORMED A DEMONSTRATION AND PROVIDED TRAINING TO ENSURE THAT THE PROPER SAMPLING TECHNIQUE IS UTILIZED. THE SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR ETHYLENE OXIDE (ETO) STERILIZATION AND THEN RETURNED TO OLYMPUS FOR A SECONDARY CULTURING BY AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS). NO FURTHER STERILIZATION WAS NEEDED AS THE SCOPE CULTURED NEGATIVE FOR MICROBIAL GROWTH. A PHYSICAL EVALUATION WAS THEN PERFORMED ON THE RETURNED DEVICE. THE INTERNAL CHANNELS OF THE DEVICE WERE EXAMINED USING A BORESCOPE AND THE FOLLOWING OBSERVATIONS WERE NOTED: A BLACK STAIN LOCATED INSIDE THE MIDDLE SECTION OF THE INSTRUMENT CHANNEL. FURTHER INSPECTION FOUND MULTIPLE KINKS LOCATED AT THE CHANNEL FROM THE BENDING SECTION SIDE AND A YELLOWISH STAIN. THE SUCTION CHANNEL WAS INSPECTED AND FOUND ADDITIONAL KINKS AND A GRAYISH STAIN INSIDE THE CHANNEL FROM THE SCOPE CONNECTOR SIDE. ADDITIONALLY, THE IMAGE WAS FOUND TO BE WITHIN SPECIFICATION. THE SCOPE PASSED LEAK TESTING. THE SCOPE WILL BE SERVICED AND BE RETURNED TO THE USER FACILITY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY STATES THAT THE MINIMUM EFFECTIVE CONCENTRATION OF THE USER FACILITY¿S AER IS BEING CHECKED WITH EACH USE. THE CHANNEL OF THE ENDOSCOPES IS BRUSHED DURING MANUAL CLEANING WITH AN OLYMPUS BRUSH THAT IS BEING SUPPLIED AS PART OF THE STUDY. THE ENDOSCOPE¿S PRE-CLEANING IS PERFORMED IMMEDIATELY AFTER EACH PROCEDURE. THE ENDOSCOPE IS LEAK TESTED PRIOR TO MANUAL CLEANING WITH A LEAK TESTER MANUFACTURED BY VERISCAN. THE SITE¿S AER PREVENTATIVE MAINTENANCE IS PERFORMED REGULARLY AND RECORDS ARE KEPT WITH FACILITY¿S CLINICAL ENGINEER. THE LAST REPROCESSING IN-SERVICE WAS CONDUCTED ON JUNE 2018 WITH AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST. THERE HAVE BEEN NO CHANGES TO THE FACILITY¿S REPROCESSING PERSONNEL SINCE THE INSERVICE. THE USER FACILITY REPORTS THAT ALL OF THE REPROCESSING PERSONNEL ARE TRAINED ON HOW TO PROPERLY REPROCESS AN ENDOSCOPE. THE SCOPES ARE STORED AND HUNG IN A CABINET WITH CIRCULATING AIR.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AS PART OF OUR INVESTIGATION, ON (B)(6) 2018 AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. THE ESS REPORTED THAT THE REPROCESSING STAFF UTILIZES HALYARD CHANNEL BRUSHES ON THE TJF-Q180V AND TJF-160VF DUODENOSCOPES. THE STAFF WOULD NOT REPEAT MANUAL CLEANING STEPS A SECOND TIME IF THE ADENOSINE TRIPHOSPHATE (ATP) TEST RESULTS WERE HIGHER THAN NORMAL AND WOULD PLACE THE SCOPE DIRECTLY INTO MEDIVATORS. THE ESS COVERED INFECTION CONTROL INFORMATION REFERENCED IN THE USER MANUAL AND REPROCESSING MANUAL. THE ESS ALSO RECOMMENDED THAT THE CUSTOMER CONTACT THE MANUFACTURER OF THAT EQUIPMENT FOR PROPER USE.
THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO INVESTIGATE THIS COMPLAINT TO OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS. AS PART OF OUR INVESTIGATION, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY AND PROVIDED A REPROCESSING TRAINING ON MAY 15, 2018. NO REPROCESSING DEVIATIONS WERE NOTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.
OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR ENTEROCOCCUS DURANS AFTER REPROCESSING. THE FACILITY UTILIZES A MEDIVATORS DSD EDGE, AER WITH PERACETIC ACID (PAA) TO REPROCESS THE SCOPE. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 765010 | EVIS EXERA DUODENOVIDEOSCOPE | FDT | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-160VF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |