EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Report
- Report Number
- 8010047-2022-10668
- Event Type
- Malfunction
- Date Received
- June 23, 2022
- Report Date
- November 8, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE SUBJECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. THE PHYSICAL DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. THE CUSTOMER¿S CLEANING, DISINFECTING, AND STERILIZATION PROCESS HAS BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE CUSTOMER PROVIDED CLEANING DISINFECTION AND SANITIZATION (CDS) PRACTICES (SEE B5), RESULTS OF THIRD PARTY TESTING, THE DEVICE EVALUATION, AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE POSITIVE CULTURE. A FEW DEFECTS WERE NOTED WHERE THE CELLING PLATE IS DEFORMED, DUE TO DEFORMATION, UP/DOWN KNOB DOES NOT MOVE SMOOTHLY, AIR/WATER-CYLINDER HAS DISCOLORATION, SUCTION-CYLINDER HAS DISCOLORATION, PLASTIC DISTAL END COVER IS SHAVED, LIGHT GUIDE LENS HAS A CRACK, ADHESIVE ON BENDING SECTION COVER HAS VISIBLE THREAD, CONNECTING TUBE HAS A BUCKLING, DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DOES NOT MEET THE STANDARD VALUE, AND THE UNIVERSAL CORD IS DEFORMED. HOWEVER, THESE DEFECTS ALONE ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE CUSTOMER REPORTED TO OLYMPUS, DURING ROUTINE TESTING, THE ENDOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. ALL CHANNELS WERE SAMPLED, AND 4 COLONY FORMING UNITS (CFU) OF STAPHYLOCOCCUS WARNERI AND STAPHYLOCOCCUS PASTEURI, WERE DETECTED IN THE INSTRUMENT CHANNEL. 12 CFU OF STAPHYLOCOCCUS WARNERI, STAPHYLOCOCCUS PASTEURI, AND ROTHIA AMARAE WERE DETECTED IN THE AIR/WATER CHANNEL. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
THE USER PROVIDED THEIR CDS PRACTICES OF THE SUBJECT DEVICE WHERE THE DETERGENT USED FOR PRE-CLEANING IS SEKUSEPT FORTE. WATER IS SUCTIONED THROUGH THE INSTRUMENT/SUCTION CHANNEL AND AIR/WATER CHANNEL. THE DEVICE IS MANUALLY PROCESSED WITH A KEYSURGICAL, DOPPELREINIGUNGSBÜRSTE EB10107C CLEANING BRUSH AND SEKUSEPT FORTE DETERGENT. AREAS BRUSHED MANUALLY INCLUDE: INSTRUMENT/SUCTION CHANNEL, SUCTION CYLINDER, AND THE INSTRUMENT CHANNEL OPENING. MANUAL DISINFECTION IS NOT CARRIED OUT. THE ENDOSCOPE IS STORED IN A CANTEL DRYING CABINET. STERILIZATION IS NOT PERFORMED. OLYMPUS IS THE MAINTENANCE PROVIDER OF THE SUBJECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240951 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | FDS | OLYMPUS MEDICAL SYSTEMS CORP. | GIF-H185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |