EVIS EXERA DUODENOVIDEOSCOPE
Report
- Report Number
- 2951238-2018-00750
- Event Type
- Malfunction
- Date Received
- December 7, 2018
- Date of Event
- November 8, 2018
- Report Date
- May 26, 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 WILL BE SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND TO PROVIDE AS PART OF THE PMS STUDY PROCESS, A REVIEW OF THE SAMPLING TECHNIQUE OF THE SAMPLER WHO TOOK THE SAMPLE FROM THE SCOPE WAS CONDUCTED BY OLYMPUS PERSONNEL AND NO DEVIATIONS WERE FOUND.
THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE REPROCESSING TECHNIQUE OF THE REPROCESSING TECHNICIAN AND OBSERVED THE FOLLOWING DEVIATIONS: THE PROPER SEQUENCE OF CLEANING AND REPROCESSING WAS NOT BEING CONDUCTED AS THE TECH WAS NOT USING THE SUCTION CLEANING ADAPTER AFTER BRUSHING CHANNELS WITH CHANNEL CLEANING/OPENING CLEANING BRUSHES WHICH SHOULD BE DONE AS THE LAST STEP. IN ADDITION, THE REPROCESSING TECH UTILIZED NON-OLYMPUS CHANNEL CLEANING/OPENING CLEANING BRUSHES; THE DISTAL END AROUND THE ELEVATOR WAS NOT BEING BRUSHED PROPERLY AS THE ELEVATOR WAS NOT BEING RAISED AND LOWERED THREE TIMES WHILE BRUSHING AROUND ELEVATOR/DISTAL END, THE ELEVATOR WIRE CHANNEL WAS NOT FLUSHED WITH THE WASHING TUBE PRIOR TO USING THE MEDIVATOR SCOPE BUDDY AND THE ELEVATOR WAS NOT FLUSHED PROPERLY 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 AND PROVIDED ONTRACK REPROCESSING FORMS TO THE USER FACILITY. ADDITIONALLY, THE SCOPE WAS SENT TO AN INDEPENDENT LAB TO BE RE-CULTURED AND TESTED NEGATIVE.
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 DEVICE EVALUATION RESULTS AND THE CLOSED CASE SUMMARY. A PHYSICAL EVALUATION ON THE RETURNED SCOPE WAS PERFORMED AND WAS UNABLE TO FIND ANY SIGNS OF FOREIGN MATERIAL/SUBSTANCE/STAIN INSIDE THE BIOPSY CHANNEL, BIOPSY PORT, AND SUCTION PORT/CHANNEL WHEN INSPECTED WITH TEST EQUIPMENT. ADDITIONALLY, THERE WERE ALSO NO SIGNS OF FOREIGN SUBSTANCE/MATERIALS/STAIN FOUND WITH THE INSERTION TUBE, BENDING SECTION COVER, BENDING SECTION COVER GLUE, ELEVATOR FORCEPS RAISER, DISTAL END COVER, LIGHT GUIDE LENS/GLUE,AND OBJECTIVE LENS/GLUE. THE SCOPE PASSED THE LEAK TEST. BASED ON THE EVALUATION, THE CAUSE OF THE REPORTED POSITIVE CULTURE COULD NOT BE DETERMINED AS THERE WAS NO ABNORMALITIES OR FOREIGN MATERIALS/SUBSTANCE/DEBRIS INSIDE THE BIOPSY CHANNELS OR WITH THE SCOPE. THE SUMMARY OF THE INVESTIGATION FINDINGS ARE AS FOLLOWS: -THE ORGANISM IDENTIFIED, ACINETOBACTER SP, IS MOST LIKELY OF ENVIRONMENTAL ORIGIN AND NOT HUMAN RESIDENT FLORA. -PERSISTENT ACINETOBACTER SP WAS NOT DETECTED DURING RECULTURING. -DEVIATIONS WERE OBSERVED DURING THE REPROCESSING PROCEDURE REVIEW. -NO DEVIATIONS WAS OBSERVED DURING THE SAMPLING PROCEDURE REVIEW. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT THIS PHENOMENON WAS POTENTIALLY OCCURRED DUE TO FOLLOWING: -DUE TO THE LOW NUMBER OF COLONIES, UNIQUE SPECIES AND ABSENCE OF PERSISTENT ORGANISMS IN RE-CULTURING, THIS ORGANISM IS PROBABLY THE RESULT OF ENVIRONMENTAL CONTAMINATION THAT OCCURRED DURING THE SAMPLING PROCEDURE (MICROBIOLOGICAL ANALYSIS). -WHILE INADEQUATE REPROCESSING IS PROBABLY NOT THE PRIMARY CAUSE, IT CANNOT BE COMPLETELY RULED OUT DUE TO THE DEVIATIONS REPORTED (REPROCESSING PROCEDURE REVIEW).
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUMMARY OF THE ROOT CAUSE FOR THE POST MARKET 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 STERIS 1E AER TO REPROCESS THE SUBJECT SCOPE. BASED ON THE INVESTIGATIONS INSUFFICIENT REPROCESSING FROM IMPROPER REPROCESSING PROCEDURES CANNOT BE RULED OUT AS A CONTRIBUTORY FACTORY OF THE REPORTED POSITIVE SCOPE CULTURE.
THE REPORTED SCOPE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED AN IN-SERVICE ON REPROCESSING WAS LAST PERFORMED BY AT THE USER FACILITY ON NOVEMBER 2, 2018. ALL REPROCESSING PERSONNEL WERE PROPERLY TRAINED ON NOVEMBER VISIT AND THERE HAVE BEEN NO CHANGES TO THE STAFF. THE STAFF IS FOLLOWING THE IFU'S REPROCESSING RECOMMENDATIONS. PRE-CLEANING IS BEING PERFORMED IMMEDIATELY AFTER A PROCEDURE FOLLOWING THE INSTRUCTION MANUAL'S RECOMMENDATIONS. THE ENDOSCOPE IS BEING LEAK TESTED PRIOR TO MANUAL CLEANING. THE ENDOSCOPE CHANNEL IS BRUSHED DURING MANUAL CLEANING. THE MINIMUM EFFECTIVE CONCENTRATION OF THE DISINFECTANT SOLUTION IS BEING CHECKED PRIOR TO REPROCESSING EACH SCOPES IN THE AER. THE NON-OLYMPUS AER WAS REPORTEDLY BREAKS DOWN FREQUENTLY AND IT IS UNKNOWN WHEN THE LAST MAINTENANCE WAS PERFORMED. THE SCOPE IS BEING STORED IN A STORAGE CABINET HANGING VERTICALLY. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.
OLYMPUS WAS INFORMED THAT DURING A POST MARKET SURVEILLANCE STUDY THE SCOPE CULTURED POSITIVE FOR A HIGH CONCERN MICROORGANISM, ACINETOBACTER SPECIES, AFTER REPROCESSING. THERE WERE NO ASSOCIATED PATIENT INFECTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 980267 | 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| DETERGENT ¿ MEDIVATORS INTERCEPT| DISINFECTANT ¿ PARACETIC ACID STERIS| LEAK TESTER - OLYMPUS MU-1 |