EVIS LUCERA ELITE DUODENOVIDEOSCOPE
Report
- Report Number
- 8010047-2021-15996
- Event Type
- Injury
- Date Received
- December 13, 2021
- Date of Event
- May 7, 2021
- Report Date
- May 10, 2024
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FDT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. THEREFORE, OLYMPUS COULD NOT INVESTIGATE THE SUBJECT DEVICE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM THE USER, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE CLEANING, DISINFECTION AND STERILIZATION (CDS) WAS INSUFFICIENT AND/OR INAPPROPRIATE.
THERE IS MORE INFORMATION ON THE DEVICE EVALUATION. CORRECTION IS BEING MADE FOR INFORMATION NOT INCLUDED IN THE SUBMITTED MDRS (CUSTOMER REPROCESSING INFORMATION, B6, E1, G2, H6). THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. REPROCESSING INFORMATION OF THE FACILITY: · AIR/WATER (AW) CHANNEL CLEANING ADAPTER IS NOT USED. · IT IS UNKNOWN WHETHER THE BIOPSY CHANNEL WAS BRUSHED. · IT IS UNKNOWN WHETHER THE SUCTION CHANNEL WAS BRUSHED. · IT IS UNKNOWN WHETHER THE BIOPSY PORT WAS BRUSHED. · IT IS UNKNOWN WHETHER THE FORCEPS ELEVATOR WAS BRUSHED. · THE REPROCESSORS USED ARE OER-3 AND OER-4, BUT THE SERIAL NUMBER AND THE DATE WHEN THE DISINFECTANT WAS LAST REPLACED ARE UNKNOWN. BASED ON THE FOLLOWING INVESTIGATION RESULTS, IT CANNOT BE DETERMINED WHETHER THIS DEVICE MAY HAVE BEEN INVOLVED IN THE CAUSE OF THE INFECTION OF THE PATIENT. PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0" WAS DETECTED IN BILE CULTURES AND/OR BLOOD CULTURES OF THE PATIENT. AS A RESULT OF THE CULTURE TESTING OF THE DEVICE, WHICH WAS PERFORMED ONLY ONCE, MULTIPLE BACTERIA WERE DETECTED, BUT PSEUDOMONAS AERUGINOSA WAS NOT DETECTED. ADDITIONALLY, NO BACTERIA WERE DETECTED FROM THE AIR SUPPLY / WATER SUPPLY CHANNEL. FROM THE CONFIRMATION RESULTS OF THE REPROCESS PROCEDURE AT THE FACILITY, IT WAS CONFIRMED THAT THERE WAS A CLEAR DEVIATION FROM INSTRUCTIONS FOR USE (IFU) THAT THE AIR/WATER SUPPLY CHANNEL CLEANING ADAPTER WAS NOT USED FOR CLEANING THE AW CHANNEL. SINCE THE PRODUCT WAS NOT RETURNED, VISUAL CONFIRMATION AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED.
INVESTIGATION ACTIVITIES WERE PERFORMED BY OLYMPUS (PER CAPA-201237), AND THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE PRODUCT (TJF-Q290V - S/N: (B)(6) WAS DELIVERED ON 01APR2021. THE REPORTED EVENT OCCURRED 36 DAYS AFTER THE DEVICE WAS DELIVERED. THERE IS NO HISTORY OF THIRD-PARTY REPAIR FOR THE SUSPECT DEVICE. PRIOR TO THE REPORTED EVENT, THE FOLLOWING PRODUCT TRAINING WAS PROVIDED BY OLYMPUS: DEMONSTRATION AND/OR EXPLANATION OF REPROCESSING STEP WAS CONDUCTED AT THE TIME OF PRODUCT DELIVERY. THE TRAINING LIKELY INCLUDED "TJF-Q290V MANUAL CLEANING POINTS" AND "NOTES ON REPROCESSING TJF-Q290V WITH OER-3/4/5." AFTER THIS INITIAL TRAINING, THERE WAS NO PERIODIC TRAINING CONDUCTED BY OLYMPUS. AFTER THE REPORTED EVENT, NO FURTHER PRODUCT TRAINING WAS CONDUCTED BY OLYMPUS. THE FACILITY REPROCESSES THE DEVICE USING THEIR OWN METHOD. THE FACILITY HAS ITS OWN KNOWLEDGE AND EXPERIENCE REGARDING THE PRODUCT AND THEIR CLINICAL ENGINEER DETERMINES THE TASKS. FURTHERMORE, AFTER ALL THE PROCEDURES FOR THE DAY ARE COMPLETED, ALCOHOL FLUSHING IS PERFORMED USING AN AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE DEVICES ARE THEN HUNG IN THE TEMPORARY STORAGE AREA TO DRY NATURALLY BEFORE BEING STORED IN THE VAULT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY (PER CAPA-201237 INTERVIEW). THE FACILITY REPORTED THAT AT THE TIME OF THE EVENT, DEVICE REPROCESSING WAS NOT CONDUCTED ACCORDING TO THE OLYMPUS INSTRUCTIONS FOR USE (IFU) MANUAL. IN RESPONSE TO THE OCCURRENCE, THE PUBLIC HEALTH CARE CENTER AND THE IN-HOSPITAL INFECTION CONTROL DEPARTMENT INSTRUCTED TO PERFORM REPROCESSING OPERATIONS IN ADHERENCE TO THE DESCRIPTIONS IN THE IFU. AS A RESULT, MOST REPROCESSING OPERATIONS HAVE SINCE BEEN PERFORMED IN ACCORDANCE WITH IFU. HOWEVER, THE FACILITY PERFORMS THE FOLLOWING REPROCESSING STEPS PER THEIR INTERNAL PROCEDURE: 1. THE AIR/WATER CHANNEL CLEANING ADAPTER IS NOT USED DURING THE BED-SIDE CLEANING. 2. WHEN CLEANING CHANNELS, A MOTOR-DRIVEN FLUID FEEDING PUMP IS USED FOR CIRCULATION. 3. ANY ENZYME-BASE DETERGENT IS NOT USED FOR THE BED-SIDE CLEANING AND MANUAL CLEANING. ONCE CLEANED, THE ENDOSCOPES ARE DRIED NATURALLY, AND HUNG IN THE ENDOSCOPE STORAGE CHAMBER. VISUAL AND FUNCTIONAL CHECKS OF THE ENDOSCOPE ARE PERFORMED AT THE BEGINNING AND END OF EACH DAY. HOWEVER, THE ENDOSCOPE IS NOT INSPECTED FOR MINUTE DAMAGES OR DETERIORATIONS OF ADHESIVES. IF A SIGNIFICANT IRREGULARITY IS OBSERVED, OR WHEN REQUESTED BY THE PHYSICIAN, THE DEVICE IS SENT FOR REPAIR. FOR THE ENDOSCOPE (TJF), A QUICK REFERENCE GUIDE FOR REPROCESSING OPERATIONS CAN BE FOUND ON THE WALL OF THE REPROCESSING ROOM. COMMON CLEANING AND DISINFECTION OPERATIONS ARE OUTSOURCED TO A THIRD-PARTY COMPANY (NIKKEI SERVICE). THE OPERATIONS MANUAL IS CREATED AS FOLLOWS: 1. THE FACILITY CREATES THE MANUAL. 2. THE THIRD-PARTY COMPANY CHECKS THE FACILITY¿S MANUAL. AN EXPERT FROM THE THIRD-PARTY COMPANY REVIEWS THE MANUAL AND DISCUSSES TO ACHIEVE A CONSENSUS OF OPERATIONS WITH THE FACILITY. 3. THE THIRD-PARTY COMPANY THEN CREATES THE FINALIZED MANUAL AFTER THE EXPERT REVIEW. 4. THE FACILITY VERIFIES THE THIRD-PARTY¿S FINALIZED MANUAL. PER THE FACILITY, NEW STAFF MEMBERS ARE NOT ISSUED ACCESS TO THE REPROCESSING DEVICE UNTIL HE/SHE CAN PERFORM THE REPROCESSING PROCEDURES CORRECTLY. TO PREVENT FUTURE OCCURRENCES OF INFECTION, AN INTRA-FACILITY PROCESS HAS BEEN ESTABLISHED FOR CHECKING THE OPERATIONS OF THE DEVICE OPERATORS AT LEAST ONCE A YEAR. BASED ON THE ADDITIONAL INFORMATION OBTAINED BY OLYMPUS, A RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND THE REPORTED PATIENT INFECTION COULD NOT BE CONFIRMED. THEREFORE, THERE IS NO CHANGE TO THE PREVIOUSLY REPORTED LEGAL MANUFACTURER¿S INVESTIGATION FINDINGS.
THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM PHARMACEUTICALS AND MEDICAL DEVICES AGENCY WITH THE REPORT FROM THE USER, IT WAS FOUND THAT PSEUDOMONAS AERUGINOSA SIMILAR TO THAT OF THE PREVIOUS PROCEDURE WAS DETECTED IN 6 PATIENTS WHO WERE USED THE DUODENOVIDEOSCOPE. THE DETAILS OF THE PROCESS ARE AS FOLLOWS. (B)(6) 2021, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND BILE DUCT STONE REMOVAL WERE PERFORMED USING THE SUBJECT DEVICE, AND BILE CULTURE WAS PERFORMED AT THAT TIME. AFTER THAT, PSEUDOMONAS AERUGINOSA, KLEBSIELLA, CITROBACTER-POSITIVE WITH POT NUMBER "307-0." (B)(6) 2021. THIS PATIENT WAS RECOVERED AND DISCHARGED. (B)(6) 2021. THERE IS A REPORT OF DETECTION OF PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0". THE USER FACILITY THOUGHT IT WAS ALREADY OWNED BY THE PATIENT. (B)(6) 2021. SINCE (B)(6) 2021, PSEUDOMONAS AERUGINOSA WITH POT NUMBER "307-0" WAS DETECTED IN BILE OR BLOOD SAMPLES OF 4 PATIENTS WHO UNDERWENT ERCP USING THE SUBJECT DEVICE. (B)(6) 2021, THE SAME POT-TYPE PSEUDOMONAS AERUGINOSA WAS DETECTED FROM THE SUBJECT DEVICE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) OBTAINED ADDITIONAL INFORMATION ABOUT THE 3RD PATIENT ((B)(6)) THAT WAS USED (B)(4) FROM THE USER AS FOLLOWING. (B)(6) 2021; USES (B)(4), JUNE 2; USES (B)(4), JUNE 8; USES (B)(4). PATIENT: (B)(6). DIAGNOSIS: CHOLANGIOCARCINOMA OF THE HEPATIC HILUM. COURSE: MAY 26; FEVER, CHOLANGITIS DIAGNOSED, SUSPECTED LIVER ABSCESS (ENTEROCOCCUS FAECIUM DETECTED IN BLOOD CULTURE). ANTIBACTERIAL TREATMENT STARTED. JUNE 2ND AND 8TH; ENBD REPLACEMENT, ETC. (P. AERUGINOSA DETECTED FROM JUNE 8TH IN BILE CULTURE). JULY 29; RIGHT HEPATECTOMY, BILIARY RECONSTRUCTION. THE COURSE IS GOOD AND HE IS CURRENTLY UNDERGOING ADJUVANT CHEMOTHERAPY. THE USER COMPLETED THE INTENDED PROCEDURE WITH THE SUBJECT DEVICE. CURRENTLY THE USER DOES NOT USE THE SUBJECT DEVICE. THE USER REPORTED THIS EVENT TO A LOCAL ((B)(6)) HEALTH CENTER. OMSC WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. (B)(6) 2021, SCOPE EXTERIOR WIPE: MICROCOCCUS LUTEUS (+) SUCTION VALVE (SONICATION): (B)(6). (+) AIR/WATER VALVE (SONICATION): GRAM POSITIVE ROD, KOCURIA SP., MICROCOCCUS LUTEUS (+) INSTRUMENT CHANNEL PORT (SONICATION): BACILLUS CEREUS, S.EPIDERMIDIS (+) FORCEPS ELEVATOR (SONICATION): MORAXELLA SP, ROSEOMONAS MUCOSA (+) SCOPE STORAGE: BACILLUS CEREUS (+) SCOPE DRYING PLACE (FRONT SIDE): BACILLUS CEREUS, S.AUREUS, PSEUDOMONAS LUTEOLA(P.STUTZERI GROUP) (+) SCOPE DRYING PLACE (BACK SIDE): BACILLUS CIRCULANS, PANTOEA SEPTICA (+). THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-3/4, USING PERACETIC ACID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1887388 | EVIS LUCERA ELITE DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | AIZU OLYMPUS CO., LTD. | TJF-Q290V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |