EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00716
- Event Type
- Malfunction
- Date Received
- November 21, 2018
- Date of Event
- October 11, 2018
- Report Date
- May 21, 2020
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDT
- PMA / PMN Number
- K024033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
THE SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR ETHYLENE OXIDE (ETO) STERILIZATION AND THEN RETURNED TO THE MANUFACTURE FOR A PHYSICAL EVALUATION. A VISUAL INSPECTION WAS PERFORMED \AND IDENTIFIED EXCESSIVE AMOUNTS OF FOREIGN YELLOW/BROWN SUBSTANCE THROUGHOUT THE INSIDE OF THE INSTRUMENT CHANNEL AND SUCTION CHANNEL. THERE WERE NO SIGNS OF FOREIGN SUBSTANCE/MATERIALS FOUND WITH THE EXTERNAL INSERTION TUBE, BENDING SECTION COVER, BENDING SECTION COVER GLUE, LIGHT GUIDE LENS/GLUE, AND OBJECTIVE LENS/GLUE. A LEAK TEST WAS NOT PERFORMED AS THE ELEVATOR FORCEP RAISER AND DISTAL END COVER WERE DISASSEMBLED DURING THE DECONSTRUCTIVE SAMPLE TESTING. THE CAUSE OF THE FOREIGN YELLOW/BROWN SUBSTANCE CANNOT BE DETERMINE AT THIS TIME AS THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FEB TO FDT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND FOUND THE TECHNICIAN WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING. IN ADDITION, THE USER FACILITY IS NOT PERFORMING PROPER CLEANING TO THE ELEVATOR AT THE DISTAL END AREA. THE ESS PROVIDED THE FOLLOWING RECOMMENDATIONS: USE OF OLYMPUS CHANNEL CLEANING / CHANNEL OPENING CLEANING BRUSHES. TO RAISE AND LOWER THE ELEVATOR THREE TIMES WHILE BRUSHING AROUND THE ELEVATOR AND DISTAL END. USE A SUCTION CLEANING ADAPTER AFTER BRUSHING CHANNELS WITH CHANNEL CLEANING/OPENING CLEANING BRUSH. PROPERLY BRUSH THE DISTAL END WITH AN MAJ-1534 BRUSH. FLUSH THE ELEVATOR WIRE CHANNEL WITH WASHING TUBE PRIOR TO UTILIZING MEDIVATOR SCOPE BUDDY AND PROPERLY FLUSH AROUND ELEVATOR USING A 30CC SYRINGE WITH DETERGENT SOLUTION AND WATER. THE ESS CONCLUDED BY CONDUCTING A REPROCESSING IN-SERVICE TRAINING THAT INCLUDED ALL CLEANING, DISINFECTION AND STERILIZATION INFORMATION THAT IS CONTAINED IN THE REPROCESSING/INSTRUCTION MANUAL. AS PART OF THE PMS STUDY PROCESS, OLYMPUS PERSONNEL CONDUCTED A REVIEW OF THE SAMPLING TECHNIQUE OF THE TECHNICIAN WHO TOOK THE SAMPLE FROM THE SCOPE AND THERE WERE NO DEVIATIONS FOUND.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. AS PART OF THE PMS STUDY PROCESS, SCOPE INSPECTION WAS PERFORMED AT THIRD PARTY LABORATORY. BELOW IS THE SUMMARY CASE REPORT FOR THIS SCOPE. THE SUMMARY OF THE INVESTIGATION FINDINGS ARE AS FOLLOWS; THIS ORGANISM IS AN ENVIRONMENTAL CONTAMINANT AND NOT HUMAN RESIDENT FLORA. SEVERAL DEVIATIONS IN THE SAMPLING PROCEDURE WERE REPORTED BY A NURSE IN INFECTION CONTROL AT THE SITE. ACINETOBACTER CALCOACETICUS WAS NOT REISOLATED FROM THE DIFFERENT TESTED PARTS OF THE ENDOSCOPE. THE RESULTS OF THIS STUDY DID NOT HIGHLIGHT ANY AREA IN THE DISTAL END OF THE SCOPE WHERE CONTAMINATION COULD PERSIST AFTER A COMPLETE REPROCESSING PROCEDURE. THE NATURE AND NUMBER OF MICROORGANISMS FOUND AFTER DISMANTLING INDICATE THAT THE CONTAMINATION WAS MORE LIKELY DUE TO A CONTAMINATION OF THE ENDOSCOPE AND/OR THE SAMPLES DURING STORAGE AND/OR DISMANTLING THAN TO A DESIGN FLAW IN THE ENDOSCOPE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THIS PHENOMENON WAS POSSIBLY OCCURRED DUE TO FOLLOWING; CONSIDERING THE NATURE OF THE MICROORGANISMS FOUND DURING DESTRUCTIVE SAMPLING AND THE FACT THAT SAMPLES WERE COLLECTED IN A NON-CONTROLLED ENVIRONMENT, THERE IS A HIGH PROBABILITY THAT THE CONTAMINATION FOUND OCCURRED DURING SAMPLING RATHER BEING A TRUE CONTAMINATION OF THE ENDOSCOPE CHANNELS (DESTRUCTIVE SAMPLING). ENVIRONMENTAL CONTAMINATION COULD HAVE ORIGINATED FROM STAFF DUE TO IMPROPER SAMPLING (SAMPLING PROCEDURE REVIEW).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND TO UPDATE THE FOLLOWING SECTIONS: THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) NOTED THE EFFECTIVE CONCENTRATION OF THE CLEANING DETERGENT AND DISINFECTANT SOLUTION IS BEING CHECKED PRIOR TO REPROCESSING EVERY SCOPE IN THE AER. THE USER FACILITY UTILIZES THE STERIS 1E AS THEIR AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE AER BREAKS DOWN FREQUENTLY AND THE ESS IS NOT SURE WHEN THE LAST PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE AER. THE SCOPE CHANNEL IS BEING BRUSHED DURING MANUAL CLEANING. PRE-CLEANING IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE AND THEY ARE FOLLOWING THE IFU'S RECOMMENDATIONS. PRIOR TO MANUAL CLEANING, THE SCOPE IS BEING LEAK TESTED. THE LAST ESS REPROCESSING IN-SERVICE WAS PERFORMED ON (B)(6) 2018. THERE HAVE BEEN NO CHANGES TO THE REPROCESSING STAFF, AND ALL ARE PROPERLY TRAINED. THE SCOPE IS STORED IN A STORAGE CABINET, AND HANGING VERTICALLY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUMMARY OF THE ROOT CAUSE FOR THE POSTMARKET SURVEILLANCE WITH THE REFERENCED TJF STUDY. THERE WERE NO DEVIATIONS OBSERVED DURING THE ENVIRONMENTAL INVESTIGATION AND THE AUTOMATED ENDOSCOPE REPROCESSING (AER) MACHINE INSPECTION. THE USER FACILITY USED A MEDIVATORS DSD EDGE TO REPROCESS THE SUBJECT SCOPE. BASED ON THE INVESTIGATIONS, CONTAMINATION FROM IMPROPER SAMPLING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED POSITIVE SCOPE CULTURE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) PROVIDED A CLOSED CASE SUMMARY REPORT. THE REPORT INDICATES THAT A DESTRUCTIVE SCOPE SAMPLING WAS PERFORMED AND FOUND THERE WAS NO CONTAMINATION ON THE INTERNAL SURFACES THAT WOULD SUGGEST A FLAW IN DISTAL END DESIGN. THE DETECTED CONTAMINATION APPEARS TO HAVE ORIGINATED FROM CHANNELS. THE DUODENOSCOPE DID NOT SHOW EVIDENCE OF FLUID INGRESS. ADDITIONALLY, AN ENVIRONMENTAL INVESTIGATION WAS OBSERVED BUT NO DEVIATIONS WERE NOTED. THE EXACT CAUSE CANNOT BE CONFIRMED, HOWEVER, SINCE IT DOES NOT APPEAR TO BE DUE TO A DESIGN ISSUE THE POTENTIALLY CAUSES OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE STAFF FROM IMPROPER SAMPLING OR ENVIRONMENTAL CONTAMINATION DUE TO THE OCCURRENCE OF LOW CONCERN ORGANISMS.
THE REPORTED SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY OF THE REPORTED SCOPE SHOWED THE SCOPE WAS PURCHASED ON (B)(6) 2015 AND WAS LAST SERVICED ON AUGUST 25, 2018. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. THE INSTRUCTION MANUAL PROVIDES WARNING WHICH STATES, ¿ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE ELEVATOR WIRE CHANNEL AND ALL ACCESSORIES USED WITH THE ENDOSCOPE DURING THE PATIENT PROCEDURE, SUCH AS ALL VALVES, MUST BE CLEANED AND HIGH-LEVEL DISINFECTED OR STERILIZED AFTER EACH PATIENT PROCEDURE, EVEN IF THE CHANNELS OR ACCESSORIES WERE NOT USED DURING THE PATIENT PROCEDURE. INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THESE COMPONENTS MAY POSE AN INFECTION CONTROL RISK TO PATIENTS AND/OR OPERATORS.¿
OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR ACINETOBACTER CALCOACETICUS AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 937504 | EVIS EXERA DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-160VF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AER: STERIS 1E| BRUSH: SINGLE USE, ENDOCHOICE HEDGEHOG| CLEANING DETERGENT: MEDIVATORS INTERCEPT| DISINFECTANT SOLUTION ¿ PARACETIC ACID STERIS| LEAK TESTER: OLYMPUS MU-1 |