EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00807
- Event Type
- Malfunction
- Date Received
- December 26, 2018
- Date of Event
- November 15, 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 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 INSPECTION OF THE AUTOMATED ENDOSCOPE REPROCESSOR MACHINE, MEDIVATORS DSD EDGE, AND THE ENVIRONMENTAL INVESTIGATION. BASED ON THE INVESTIGATIONS (MICROBIOLOGICAL ANALYSIS, REPROCESSING PROCEDURE REVIEW, DEVICE EVALUATION), THE GLUE CONDITION DUE TO INSUFFICIENT/IMPROPER REPROCESSING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED EVENT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION TO THE AWARE DATE ON THE PREVIOUS SUPPLEMENTAL REPORT. THE AWARE DATE FOR THE SAMPLING REVIEW RESULTS IS ON DECEMBER 16, 2018 AND NOT JANUARY 16, 2019.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE FROM FEB TO FDT.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUMMARY OF THE DECONSTRUCTIVE SAMPLING TESTING. THE SUBJECT SCOPE WAS SENT FOR DESTRUCTIVE SAMPLING AT AN EXTERNAL LABORATORY. AFTER THE DISASSEMBLING, THE FOLLOWING WAS OBSERVED: THE DESTRUCTIVE SAMPLING IDENTIFIED ENTEROCOCCUS FAECIUM AND KLEBIELLA PNEUMONIAE THAT ARE CATEGORIZED HIGH CONCERN ORGANISMS. KLEBIELLA PNEUMONIAE WAS ALSO IDENTIFIED IN THE INITIAL SAMPLING. IN ADDITION, THE EXTERNAL EXPERT OBSERVED: -DETERIORATION AND BLEACHING OF THE GLUE OF THE BENDING SECTION AND AROUND THE NOZZLE AT THE DISTAL END OF THE SCOPE. - THERE WAS ALSO A SURPLUS OF GLUE AROUND THE NOZZLE, THE LIGHT GUIDE LENS AND THE OBJECTIVE LENS AT THE DISTAL END. - THERE WAS SOME OXIDATION NOTED UNDER THE GLUE OF THE DISTAL LIGHT GUIDE LENS. - THERE WERE HOLES IN GLUE AROUND THE NOZZLE. THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FEB TO FDT.
AS PART OF THE POST MARKET SURVEILLANCE STUDY PROCESS, OLYMPUS PERSONNEL CONDUCTED A REVIEW OF THE SAMPLING PROCESS A REVIEW OF THE SAMPLING TECHNIQUE OF THE SAMPLER WHO TOOK THE SAMPLE FROM THE SCOPE AND THERE NO DEVIATIONS WERE FOUND. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO REVIEW THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND FOUND THE TECHNICIAN WAS NOT FOLLOWING THE PROPER SEQUENCE OF CLEANING AND REPROCESSING AND IS NOT PERFORMING PROPER CLEANING TO THE ELEVATOR AT THE DISTAL END. THE ESS OBSERVED THE USER FACILITY IS: NOT USING OLYMPUS CHANNEL CLEANING/OPENING CLEANING BRUSHES. CUSTOMER USES ANOTHER MANUFACTURER'S BRUSH. NOT USING SUCTION CLEANING ADAPTER AFTER BRUSHING CHANNELS WITH CHANNEL CLEANING/OPENING CLEANING BRUSHES. CUSTOMER IS DOING THIS AS LAST STEP NOT RAISING AND LOWERING THE ELEVATOR THREE TIMES WHILE BRUSHING AROUND ELEVATOR AND DISTAL END. NOT PROPERLY BRUSHING THE DISTAL END AROUND THE ELEVATOR WITH THE MAJ-1534 FOR THE TJF-160VF SCOPE. NOT FLUSHING THE ELEVATOR WIRE CHANNEL WITH THE WASHING TUBE PRIOR TO SCOPE BUDDY ON THE TJF-160VF SCOPE. NOT FLUSHING PROPERLY AROUND THE ELEVATOR WITH A SYRINGE WITH DETERGENT AND RINSE WATER. THE ESS CONCLUDED BY RECOMMENDING THE USER FACILITY FOLLOW THE CORRECT REPROCESSING STEPS IN ORDER ACCORDING THE INSTRUCTION/REPROCESSING MANUAL.
AS PART OF THE POST MARKET STUDY, THE SCOPE WAS STERILIZED AND RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION ON THE SCOPE IDENTIFIED AN EXCESS AMOUNT OF FOREIGN YELLOWISH COLOR SUBSTANCE THROUGHOUT THE INSIDE THE INSTRUMENT CHANNEL AND SUCTION CHANNEL. THERE WAS NO SIGN OF FOREIGN SUBSTANCE/MATERIALS FOUND ON THE EXTERNAL AREAS OF THE INSERTION TUBE, BENDING SECTION COVER, AND DISTAL END. AS A RESULT OF THE DESTRUCTIVE TESTING, THE SCOPE WAS RECEIVED WITHOUT THE DISTAL END COVER AND THE ELEVATOR FORCEPS RAISER, THEREFORE, A LEAK TEST COULD NOT BE PERFORMED. A REVIEW OF THE SCOPE'S INSTRUMENT HISTORY RECORDS INDICATES THE SCOPE WAS LAST REPAIRED ON MAY 11, 2018. THE CAUSE OF THE FOREIGN YELLOW/BROWN SUBSTANCE AND THE REPORTED POSITIVE CULTURE CANNOT BE DETERMINE AT THIS TIME AS THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.
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, KLEBSIELLA PNEUMONIA, AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1034199 | EVIS EXERA DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-160VF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AER: MEDIVATOR DSD EDGE |