EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00808
- Event Type
- Malfunction
- Date Received
- December 26, 2018
- Date of Event
- November 18, 2018
- Report Date
- May 18, 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
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 THE RESULTS OF THE PHYSICAL EVALUATION. THE SUBJECT SCOPE WAS SENT FOR DESTRUCTIVE SAMPLING. THE RESULTS OF THE DESTRUCTIVE SAMPLING HAVE NOT BEEN FINALIZED. THE SCOPE WAS THEN SENT TO AN INDEPENDENT LABORATORY FOR ETHYLENE OXIDE (ETO) STERILIZATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SCOPE AND WAS ABLE TO IDENTIFY EXCESSIVE AMOUNTS OF FOREIGN YELLOWISH SUBSTANCE THROUGHOUT INSIDE THE INSTRUMENT CHANNEL AND SUCTION CHANNEL. THERE WAS NO SIGN 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. BASED ON THE EVALUATION RESULTS, INSUFFICIENT MAINTENANCE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE YELLOW STAINS. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. AS A PREVENTIVE MEASURE, THE REPROCESSING 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.
THIS SUPPLEMENTAL REPORT WILL BE SUBMITTED TO PROVIDE THE SUMMARY OF THE DECONSTRUCTIVE SAMPLING TEST RESULTS. THE SUMMARY OF THE REPORT IS THE FOLLOWING: THE DESTRUCTIVE SAMPLING IDENTIFIED RALSTONIA PIKETTII THAT IS CATEGORIZED HIGH CONCERN ORGANISMS. NONE OF THE HIGH CONCERN ORGANISMS WERE IDENTIFIED IN THE INITIAL SAMPLING. IN ADDITION, THE EXTERNAL EXPERT ALSO OBSERVED: DETERIORATION AND BLEACHING OF THE GLUE OF THE BENDING SECTION, THE DISTAL END COVER, AROUND THE DISTAL NOZZLE AND THE DISTAL OBJECTIVE LENS. A SURPLUS OF GLUE OF NOTED AROUND THE DISTAL NOZZLE AND DISTAL END COVER. AN ABSENCE OF GLUE OF THE HEAD OF SCREW AT THE DISTAL END COVER. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUMMARY OF THE ROOT CAUSE ANALYSIS REPORT FOR THE POSTMARKET SURVEILLANCE WITH THE REFERENCED TJF STUDY. THERE WERE NO DEVIATIONS OBSERVED DURING THE OF THE AUTOMATED ENDOSCOPE REPROCESSOR MACHINE (STERIS 1E) INSPECTION AND OR THE ENVIRONMENTAL INVESTIGATION. BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS, REPROCESSING PROCEDURE REVIEW), INSUFFICIENT/IMPROPER REPROCESSING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED EVENT.
THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND OBSERVED THE FOLLOWING: LEAK TESTER WAS NOT BEING INSPECTED PRIOR TO USE TO ENSURE IT IS EMITTING AIR. SCOPE WAS NOT BEING WIPED DOWN AT THE BEGINNING; INSTEAD WAS THE WIPE DOWN OF THE SCOPE WAS DONE AT THE MIDDLE OF THE MANUAL CLEANING PROCESS. IN ADDITION, THE ESS OBSERVED THE PROPER SEQUENCE OF CLEANING AND REPROCESSING WAS NOT BEING CONDUCTED. (IE: THE CHANNEL OPENING CLEANING BRUSH AS THE FIRST STEP OF MANUAL CLEANING WAS NOT BEING DONE. AN OLYMPUS CHANNEL CLEANING/OPENING CLEANING BRUSHES WAS NOT BEING USED. THE ELEVATOR WAS NOT BEING RAISED AND LOWERED THREE TIMES WHILE BRUSHING AROUND ELEVATOR AND DISTAL END. THE ELEVATOR WAS NOT RAISED AND LOWERED DURING THE USE OF THE SUCTION CLEANING ADAPTER. THE DISTAL END AROUND THE ELEVATOR IS NOT BEING BRUSHED PROPERLY WITH THE MAJ-1888 FOR THE TJF-Q180V SCOPE AND THE MAJ-1534 FOR THE TJF-160VF SCOPE. THE ELEVATOR WIRE CHANNEL WAS NOT FLUSHED WITH THE WASHING TUBE PRIOR TO SCOPE BUDDY ON THE TJF-160VF SCOPE.) THE ESS CONCLUDED BY RECOMMENDING THE USER FACILITY FOLLOW THE CORRECT REPROCESSING STEPS IN ORDER ACCORDING THE INSTRUCTION/REPROCESSING MANUAL. ADDITIONALLY, AS PART OF THE PMS STUDY PROCESS, OLYMPUS PERSONNEL CONDUCTED A REVIEW OF THE SAMPLING TECHNIQUE OF THE SCOPE SAMPLER. THERE WERE NO DEVIATIONS NOTED.
THE REPORTED SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, HOWEVER, OLYMPUS WILL CONTINUE TO INVESTIGATE. AS PART OF OUR INVESTIGATION IN THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO INVESTIGATE THE USER FACILITY¿S REPROCESSING PRACTICES. IF ADDITIONAL INFORMATION BECOMES OR IF THE DEVICE IS RETURNED AT A LATER DATE, THIS REPORT WILL BE UPDATED AND SUPPLEMENTED ACCORDINGLY.
OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR MICROORGANISMS, ENTEROCOCCUS FAECALIS, AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034200 | EVIS EXERA DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-160VF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AER: STERIS |