EVIS EXERA III DUODENOVIDEOSCOPE
Report
- Report Number
- 9610595-2022-03626
- Event Type
- Malfunction
- Date Received
- November 4, 2022
- Report Date
- February 19, 2023
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- UDI-DI
- 04953170452024
- PMA / PMN Number
- K220587
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVALUATION IS NOT YET BEGUN. THE DEVICE IS BEING SENT TO AN INDEPENDENT LABORATORY FOR TESTING AND ETHYLENE OXIDE (ETO) STERILIZATION. AS SUCH, A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY RELEVANT NEW INFORMATION BECOMES AVAILABLE.
AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) PERFORMED AN IN-SERVICE AT THE FACILITY. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION AND THE DEVICE MANUFACTURING DATE. THE OLYMPUS ESS WENT ON SITE TO PERFORM THE IN-SERVICE, OBSERVING THE FACILITY TECHNICAL STAFF REPROCESSING THE DEVICE. ESS DID NOT OBSERVE ANY DEVIATIONS. CUSTOMER FOLLOWED ALL CLEANING AND REPROCESSING STEPS AS RECOMMENDED IN THE OLYMPUS REPROCESSING MANUAL INSTRUCTIONS FOR USE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION, ADDITIONAL MICROBIAL TESTING (REFER TO B6 AND H10) AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. OLYMPUS EVALUATED THE SUBJECT DEVICE. A VISUAL INSPECTION ON THE DEVICE IN THE AS RECEIVED CONDITION. AN OLYMPUS BORESCOPE WAS USED TO INSPECT THE CONDITION OF THE BIOPSY AND SUCTION CHANNEL. FIRST, THE BORESCOPE WAS INSERTED INTO THE BIOPSY CHANNEL FROM THE OPENING AT THE DISTAL END. UPON INSPECTION, LIGHT SURFACE SCRATCHES AND KINKS ON THE WALL OF THE CHANNEL WERE NOTED. THE BORESCOPE WAS INSERTED FURTHER AND FOUND LIGHT SCRATCHES THROUGHOUT THE BIOPSY CHANNEL. THE BORESCOPE WAS REMOVED AND REINSERTED THROUGH THE SUCTION CYLINDER TO INSPECT SUCTION CHANNEL. ONCE THE BORESCOPE WAS INSERTED, SCRATCHES ON THE SUCTION CYLINDER AND SUCTION CHANNEL WAS OBSERVED. IN ADDITION, THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND THERE WERE NO SIGNS OF FOREIGN MATERIAL ON THE DISTAL END OR FORCEPS ELEVATOR. IN ADDITION, THE BENDING SECTION COVER GLUE WAS CRACKED AND THE DISTAL END COVER HAD A DENT. AS PART OF THE INVESTIGATION, THE DEVICE WAS SENT TO AN INDEPENDENT LABORATORY FOR TESTING. THE INSERTION SECTION OF THE SUBJECT DEVICE WAS FOUND TO HAVE STAPHYLOCOCCUS EPIDERMIDIS GROWTH WHEN TESTED ON A BLOOD AGAR PLATE (GENERAL AGAR). VISUAL INSPECTION: THE ENDOSCOPE WAS VISUALLY INSPECTED PRIOR TO EXTRACTION. VISIBLE DEBRIS WAS NOT OBSERVED. VISIBLE DAMAGE WAS NOT OBSERVED. DISTAL END AND ELEVATOR MECHANISM: THE ENTIRE ELEVATOR AREA (FRONT, BACK, AND BOTH SIDES) WAS FLUSHED WITH 20 ML OF EXTRACTION FLUID WHILE THE ELEVATOR WAS IN THE RAISED POSITION. THE ELEVATOR WAS LOWERED AND THE ELEVATOR AREA WAS FLUSHED WITH ANOTHER 20 ML OF EXTRACTION FLUID. A STERILE BRUSH (MAJ-1888) WAS USED TO BRUSH ALL SIDES OF THE ELEVATOR MECHANISM WHILE THE ELEVATOR WAS IN THE RAISED POSITION. THE ELEVATOR WAS LOWERED AND THE BRUSHING WAS REPEATED. THE ENTIRE ELEVATOR AREA (FRONT, BACK, AND BOTH SIDES) WAS FLUSHED WITH 20 ML OF EXTRACTION FLUID WHILE THE ELEVATOR WAS IN THE RAISED POSITION. THE ELEVATOR WAS LOWERED AND THE ELEVATOR AREA WAS FLUSHED WITH ANOTHER 20 ML OF EXTRACTION FLUID. THE BRUSHING AND FLUSHING STEPS WERE REPEATED ONE FINAL TIME. A TOTAL OF 120 ML OF EXTRACTION FLUID WAS USED FOR THIS TEST SITE. AIR/WATER CHANNEL: THE AIR/WATER CHANNEL WAS EXTRACTED USING THE FLUSH METHOD. A STERILE FLUSHING TUBE WAS ATTACHED TO THE AIR PIPE, A STERILE PLUG/VALVE WAS ATTACHED TO THE AIR/WATER SUPPLY CONNECTOR ON THE LIGHT GUIDE CONNECTOR, AND A STERILE PLUG/VALVE WAS ATTACHED IN THE AIR/WATER C YLINDER ON THE CONTROL SECTION. THE AIR/WATER CHANNEL WAS FLUSHED THREE TIMES WITH 60 ML OF EXTRACTION FLUID AND AIR FROM THE LIGHT GUIDE CONNECTOR TO THE DISTAL END AND THE ELUENT WAS COLLECTED. A TOTAL OF 180 ML OF EXTRACTION FLUID WAS USED FOR THIS TEST SITE. INSTRUMENT/SUCTION CHANNEL: THE INSTRUMENT/SUCTION CHANNEL WAS EXTRACTED USING THE FLUSH/BRUSH/FLUSH METHOD. THE INSTRUMENT CHANNEL PORT AND SUCTION CYLINDER WERE PLUGGED WITH STERILE PLUGS/VALVES AND A STERILE FLUSHING TUBE WAS ATTACHED TO THE SUCTION CONNECTOR ON THE LIGHT GUIDE CONNECTOR. THE INSTRUMENT/SUCTION CHANNEL WAS FLUSHED WITH 50 ML OF EXTRACTION FLUID AND AIR FROM THE LIGHT GUIDE CONNECTOR TO THE DISTAL END AND THE ELUENT WAS COLLECTED. THE PLUG/VALVE WAS REMOVED FROM THE SUCTION CYLINDER (ON THE CONTROL SECTION). A STERILE, DISPOSABLE CHANNEL BRUSH WAS USED TO BRUSH THE SUCTION CHANNEL FROM THE CONTROL SECTION TO THE LIGHT GUIDE CONNECTOR (DOWN/UP). STERILE SCISSORS WERE USED TO CUFF OFF THE BRUSH HEAD APPROXIMATELY 1¿ ABOVE THE BRISTLES. THE BRUSH HEAD WAS COLLECTED AND PLACED INTO THE EXTRACTION CONTAINER. A NEW STERILE, DISPOSABLE CHANNEL BRUSH WAS USED TO BRUSH THE INSTRUMENT CHANNEL FROM THE CONTROL SECTION TO THE DISTAL END (DOWN/UP). STERILE SCISSORS WERE USED TO CUT OFF THE BRUSH HEAD APPROXIMATELY 1¿ ABOVE THE BRISTLES. THE BRUSH HEAD WAS COLLECTED AND PLACED INTO THE EXTRACTION CONTAINER. THE PLUG/VALVE WAS REATTACHED TO THE SUCTION CYLINDER. THE INSTRUMENT/SUCTION CHANNEL WAS FLUSHED WITH 50 ML OF EXTRACTION FLUID AND AIR FROM THE LIGHT GUIDE CONNECTOR TO THE DISTAL TIP AND THE ELUENT WAS COLLECTED. THE INSTRUMENT CHANNEL PORT WAS FLUSHED WITH 50 ML OF EXTRACTION FLUID AND AIR FROM THE INSTRUMENT CHANNEL PORT TO THE DISTAL TIP AND THE ELUENT WAS COLLECTED. A TOTAL OF 150 ML OF EXTRACTION FLUID WAS USED FOR THIS TEST SITE. INSERTION SECTION: THE INSERTION SECTION WAS EXTRACTED WITH STERILE SWABS. A SWAB WAS MOISTENED WITH EXTRACTION FLUID AND THE TEST SITE WAS SWABBED IN A SIDE-TO-SIDE MOTION. THE SWAB WAS FLIPPED OVER AND THE SAME AREA WAS SWABBED IN AN UP AND DOWN MOTION. THE HEAD OF THE SWAB WAS REMOVED AND PLACED INTO 120 ML OF EXTRACTION FLUID. THIS SWABBING PROCESS WAS THEN REPEATED WITH A DRY SWAB TO REMOVE ANY REMAINING MOISTURE FROM THE TEST SITE. ONE ADDITIONAL WET SWAB AND ONE ADDITIONAL DRY SWAB WERE USED TO COMPLETE THE EXTRACTION PROCESS. THE SWABS WERE EXTRACTED BY MANUALLY SHAKING THEM IN THE EXTRACTION FLUID 100 TIMES IN A 12-INCH PATH. MICROBIAL SCREENING: MEMBRANE FILTRATION: THE ENTIRE VOLUME OF EXTRACTION FLUID WAS FILTERED DIRECTLY THROUGH A 0.45 ¿M MEMBRANE. THE FILTER WAS RINSED THREE TIMES WITH 0.1% PEPTONE WATER (PEPW) AND PLACED INTO 100 ML OF SOYBEAN CASEIN DIGEST BROTH (SCDB) AND INCUBATED AT 35-39°C FOR 48-72 HOURS. BLOOD AGAR - COMMERCIAL TRYPTIC SOY AGAR WITH 5% SHEEP BLOOD (CBAG): THE BROTH WAS STREAKED AND INCUBATED FOR 48-72 HOURS AT 35-39°C. FOLLOWING INCUBATION, THE PLATES WERE OBSERVED FOR GROWTH. GRAM NEGATIVE SPECIES: THE BROTH WAS STREAKED ONTO MACCONKEY AGAR (MACK) AND INCUBATED FOR 48-72 HOURS AT 35-39°C. FOLLOWING INCUBATION, THE PLATES WERE OBSERVED FOR GROWTH. ORGANISM IDENTIFICATION PROCEDURES: MICROBIAL CHARACTERIZATION AND GRAM STAIN: ORGANISMS WERE EXAMINED FOR COLONY MORPHOLOGY AND ISOLATES WERE SELECTED FOR TESTING. BACTERIAL ORGANISMS WERE STREAKED ON TRYPTICASE SOY AGAR (CTSA) OR R2A AGAR AND INCUBATED AT 30-35°C UNTIL GROWTH WAS OBSERVED. COLONIES PRESENT AFTER INCUBATION WERE VERIFIED AS HAVING SIMILAR MORPHOLOGY TO THE STREAKED ORGANISM. BACTERIAL ORGANISMS WERE EXAMINED FOR GRAM STAIN REACTION AND CELL MORPHOLOGY. GENETIC IDENTIFICATION: THE DNA WAS EXTRACTED FROM EACH ORGANISM. POLYMERASE CHAIN REACTION (PCR) WAS USED TO AMPLIFY A SEGMENT OF THE DNA. FOR BACTERIA, AN APPROXIMATELY 500 BASE PAIR SEGMENT OF THE 16S RDNA WAS ANALYZED. THE DNA WAS SEQUENCED AND PLACED ON THE GENETIC ANALYZER, WHICH RECORDS THE NUCLEOTIDE BASES. THE COMPUTER ASSESSED THE QUALITY OF THE SEQUENCE AND COMPARED IT TO THE APPLICABLE LIBRARY ENTRIES TO PROVIDE AN ORGANISM MATCH. AS PART OF THE INVESTIGATION, OLYMPUS REVIEWED THE CUSTOMER¿S CLEANING DISINFECTION AND STERILIZATION PROCESSES AND FOUND NO DEVIATIONS WITH THE INSTRUCTIONS FOR USE (IFU). THE INVESTIGATION WAS UNABLE TO DETERMINE THE CAUSE OF POSITIVE CULTURE ON THE SCOPE. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU WARNS AGAINST INAPPROPRIATE REPROCESSES AS FOLLOWS: AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE SAMPLE WAS CULTURED AND TESTED POSITIVE IN THE SCOPE CHANNEL FOR MICROCOCCUS SPECIES IN THREE CONSECUTIVE SAMPLING TESTS. THE DEVICE WAS NOT USED ON A PATIENT WITH KNOWN INFECTION OF THE MICROCOCCUS SPECIES MICROORGANISM. THERE IS NO REPORTED HARM TO ANY PATIENT OR PERSONS. THE FACILITY PERFORMS ROUTINE SUCH CULTURING ACCORDING TO CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES PROTOCOL FOR SCOPE CULTURE AND SAMPLING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2530003 | EVIS EXERA III DUODENOVIDEOSCOPE | FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q190V | 04953170452024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |