EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00722
- Event Type
- Malfunction
- Date Received
- November 26, 2018
- Date of Event
- October 15, 2018
- Report Date
- April 11, 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 MAKE A CORRECTION ON THE PROCODE FROM FEB TO FDT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A SUMMARY OF THE DESTRUCTIVE SAMPLING TEST RESULTS. THE SUMMARY OF THE REPORT IS THE FOLLOWING: THERE WERE NO HIGH CONCERN ORGANISMS DETECTED DURING THE DESTRUCTIVE SAMPLING. IN ADDITION, THE EXTERNAL EXPERT OBSERVED THE FOLLOWING DURING THE DESTRUCTIVE SAMPLING: -DETERIORATION AND LIGHT BLEACHING/DISCOLORATION OF THE GLUE AT THE BENDING SECTION. -SURPLUS, BLEACHING/DISCOLORATION OF GLUE OF THE DISTAL END COVER AND AROUND THE OBJECTIVE LENS AND THE NOZZLE. -PRESENCE OF HOLES IN THE GLUE OF THE AROUND THE NOZZLE. -ABSENCE OF GLUE AT HEAD OF THE SCREW.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY AND OBSERVED THE REPROCESSING PERSONNEL WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING AS THE USER FACILITY WAS NOT USING THE CHANNEL OPENING CLEANING BRUSH AS THE FIRST STEP OF MANUAL CLEANING. THE USER FACILITY ALSO IS USING NON-OLYMPUS CHANNEL CLEANING AND CHANNEL OPENING CLEANING BRUSHES. IN ADDITION, THE USER FACILITY IS NOT PERFORMING PROPER CLEANING TO THE ELEVATOR AT THE DISTAL END AREA; NOT RAISING AND LOWERING THE ELEVATOR THREE TIMES WHILE BRUSHING AROUND THE ELEVATOR AND DISTAL END; NOT RAISING AND LOWERING THE ELEVATOR DURING THE USE OF A SUCTION CLEANING ADAPTER; NOT PROPERLY BRUSHING THE DISTAL END AROUND THE ELEVATOR WITH THE MAJ-1534 FOR THE TJF-160VF SCOPE, THE USER FACILITY IS USING MAJ-1534 BRUSHES WITH HEAVILY FRAYED BRISTLES; NOT USING SUCTION CLEANING ADAPTER AFTER BRUSHING WITH CHANNEL CLEANING/OPENING BRUSHES; NOT FLUSHING THE ELEVATOR WIRE CHANNEL WITH THE WASHING TUBE PRIOR TO USING SCOPE BUDDY FLUSHING UNIT ON THE TJF-160VF SCOPE AND THE USER FACILITY IS NOT FLUSHING PROPERLY AROUND THE ELEVATOR WITH A SYRINGE WITH DETERGENT AND RINSE WATER. THE ESS CONCLUDED BY CONDUCTING A REPROCESSING IN-SERVICE TRAINING THAT INCLUDED ALL CLEANING, DISINFECTION AND STERILIZATION INFORMATION THAT IS CONTAINED IN THE OLYMPUS REPROCESSING/INSTRUCTION MANUAL. AS PART OF THE PMS STUDY PROCESS, A SAMPLING REVIEW OF THE SAMPLING PROCESS WAS PERFORMED AND FOUND NO DEVIATIONS.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS ON THE PHYSICAL EVALUATION OF THE SCOPE. THE SCOPE WAS SENT FOR DESTRUCTIVE SAMPLING. THE DESTRUCTIVE SAMPLING WAS COMPLETED BUT THE RESULTS HAVE NOT BEEN FINALIZED. THE SCOPE WAS THEN 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 ON THE RECEIVED CONDITION AND FOUND YELLOW SUBSTANCE INSIDE THE INSTRUMENT BIOPSY CHANNEL AND SUCTION CHANNEL OF THE SCOPE. KINKS INSIDE THE INSTRUMENT CHANNEL FROM THE BENDING SECTION SIDE WERE PRESENT. ADDITIONALLY, THE IMAGE IS WORKING NORMAL. A LEAK TEST WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGED DISTAL END TIP. THE SCOPE WAS PURCHASED ON DECEMBER 2, 2009 AND THE LAST TIME THE SCOPE CAME IN FOR SERVICE WAS AUGUST 17, 2018. THE CAUSE OF THE YELLOW SUBSTANCE CANNOT BE DETERMINED. THE MOST PROBABLE CAUSE OF THE KINKS IN THE CHANNEL CAN BE ATTRIBUTED TO HANDLING/MAINTENANCE. THE REPROCESSING MANUAL PROVIDES SEVERAL WARNING AND CAUTIONS STATEMENTS IN AN EFFORT TO PREVENT CROSS CONTAMINATION. ¿AN INSUFFICIENTLY CLEANED, DISINFECTED, OR STERILIZED ENDOSCOPE AND/OR ACCESSORIES MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM. IMPROPER STORAGE PRACTICES, SUCH AS NOT THOROUGHLY DRYING EXTERNAL AND INTERNAL SURFACES (LUMENS) INCLUDING THE FORCEPS ELEVATOR RECESS PRIOR TO STORAGE, WILL LEAD TO AN INFECTION CONTROL RISK.¿ THE MANUFACTURER WILL CONTINUE TO INVESTIGATE AND OBTAIN MORE DETAILED INFORMATION REGARDING THE REPORTED EVENTS. 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 THE REFERENCED TJF STUDY. THERE WERE NO DEVIATIONS OBSERVED DURING THE MEDIVATOR DSD EDGE (AER) INSPECTION AND ENVIRONMENTAL INVESTIGATION. ALTHOUGH NO REPROCESSING PROCEDURE DEVIATIONS WERE OBSERVED, BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS, REPROCESSING PROCEDURE REVIEW, DESTRUCTIVE SAMPLING), INSUFFICIENT/IMPROPER REPROCESSING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED EVENT.
THE REPORTED SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, HOWEVER, 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 THE FOLLOWING MICROORGANISM: PSEUDOMONAS STUTZERI AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT THE CLEANING AND DISINFECTANT SOLUTIONS USED WITH THE ENDOSCOPE ARE MEDIVATORS INTERCEPT AND MEDIVATORS RAPICIDE PA. THE MINIMUM EFFECTIVE CONCENTRATION IS BEING CHECKED PRIOR TO REPROCESSING EACH SCOPE. DURING MANUAL CLEANING, THE ENDOSCOPE CHANNEL IS BEING BRUSHED USING A SINGLE USE, ENDOCHOICE HEDGEHOG BRUSH. PRE-CLEANING IS BEING PERFORMED BY FOLLOWING IFU RECOMMENDATIONS. ALL SCOPES ARE BEING LEAK TESTED USING OLYMPUS MU-1. THE USER FACILITY UTILIZES THE MEDIVATOR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER) AND REPORTEDLY HAS NO ISSUES. IT IS UNKNOWN WHEN THE LAST PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE MEDIVATOR DSD EDGE. AN IN-SERVICE TRAINING IN REPROCESSING WAS LAST CONDUCTED BY THE ESS AT THE USER FACILITY ON NOVEMBER 2ND, 2018. THERE HAVE BEEN NO CHANGES IN REPROCESSING PERSONNEL SINCE THE LAST VISIT. THE SCOPES ARE STORED IN A STORAGE CABINET, HANGING VERTICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940247 | EVIS EXERA DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-160VF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AER-MEDIVATOR DSD EDGE, 0250A| BRUSH-ENDOCHOICE HEDGEHOG| CLEANING SOLUTION-MEDIVATORS INTERCEPT| DISINFECTANT-MEDIVATORS RAPICIDE PA.| LEAK TESTER-OLYMPUS MU-1 |