GASTROINTESTINAL VIDEOSCOPE
Report
- Report Number
- 8010047-2022-04819
- Event Type
- Malfunction
- Date Received
- March 23, 2022
- Report Date
- December 14, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDS
- UDI-DI
- 04953170334115
- PMA / PMN Number
- K112680
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE WAS EVALUATED BY OLYMPUS. THE EVALUATION FOUND INSUFFICIENT OR INCORRECT REPROCESSING OF THE SCOPE AS EVIDENCED BY FOREIGN MATERIAL EXITING FROM THE AIR/WATER NOZZLE. THE INVESTIGATION IS ONGOING AND THE CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN ADDITION, THE EVALUATION FOUND THE FOLLOWING: DUE TO DAMAGE ON CH-TUBE, WATER TIGHTNESS IS LOST. C-COVER HAS A DENT. ADHESIVE ON A-RUBBER IS DETACHED. A-RUBBER HAS CLOTTING PROTEIN. CONNECTING TUBE HAS A BUCKLING. CONNECTING TUBE IS DIRTY. S-COVER HAS A SCRATCH. GRIP HAS A SCRATCH. FORCEPS CHANNEL PORT IS SHAVED. S-CYLINDER IS SHAVED. SW1 HAS A PINHOLE AND A CUT. SWITCH BOX IS DIRTY. KNOBS ARE DIRTY. UNIVERSAL CORD HAS DISCOLORATION. VIDEO CABLE HAS A SCRATCH. VIDEO CONNECTOR CASE HAS A SCRATCH. VIDEO CONNECTOR HAS A SCRATCH. LG CONNECTOR IS DIRTY. CONTROL UNIT IS DIRTY . DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP/DOWN/LEFT DIRECTIONS DO NOT MEET THE STANDARD VALUE. DUE TO DEFORMATION OF BENDING TUBE, THE PLAY OF U/D KNOB IS OUT OF THE STANDARD VALUE. DUE TO DAMAGE ON CH-TUBE, FORCEPS CANNOT BE INSERTED SMOOTHLY. DUE TO NOZZLE CLOGGING, AMOUNT OF WATER CONTACT DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, A/W SUPPLY VOLUME DOES NOT MEET THE STANDARD VALUE. DUE TO DAMAGE ON CH-TUBE, SUCTION VOLUME DOES NOT MEET THE STANDARD VALUE.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO DETERMINED HOWEVER, SINCE REPROCESSING AFTER PREVIOUS PROCEDURE WAS INAPPROPRIATE, NOZZLE WAS CLOGGED WITH FOREIGN MATERIAL SUCH AS BODY FLUID OR AN ADHERENT CAME FROM USED CHEMICAL AGENT BECAUSE REPROCESSING AFTER THE PREVIOUS PROCEDURE WAS INAPPROPRIATE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE: DANGERS, WARNINGS, AND CAUTIONS: LABELING REVIEW: USER IS ABLE TO DETECT THE SUGGESTED EVENT APPROPRIATELY BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU. OPERATION MANUAL_ PREPARATION AND INSPECTION. INSPECTION OF THE ENDOSCOPE. INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE¿S INSERTION SECTION FOR ABNORMAL SWELLING, BULGES, DENTS, OR OTHER IRREGULARITIES. INSPECTION OF THE ENDOSCOPIC SYSTEM. INSPECTION OF THE AIR-FEEDING FUNCTION. INSPECTION OF THE OBJECTIVE LENS CLEANING FUNCTION. USER IS ABLE TO REDUCE/PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU. REPROCESSING MANUAL_ PRECLEANING THE ENDOSCOPE AND ACCESSORIES. WARNING: IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IN THE PATIENT PROCEDURE ROOM IMMEDIATELY AFTER EACH PATIENT PROCEDURE. FLUSH THE AIR/WATER CHANNEL WITH WATER AND AIR_ CAUTION: TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE. MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES: IMMERSE THE ENDOSCOPE IN THE DETERGENT SOLUTION. THOROUGHLY BRUSH OR WIPE ALL EXTERNAL SURFACES OF THE ENDOSCOPE, USING CLEAN LINT-FREE CLOTHS, BRUSHES, OR SPONGES. PAY PARTICULAR ATTENTION TO THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS ON THE DISTAL END OF THE INSERTION SECTION, AND CONFIRM THAT ALL DEBRIS IS REMOVED FROM ALL SURFACES OF THE DISTAL END. FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION. REMOVE DETERGENT SOLUTION FROM ALL CHANNELS. PRESOAKING THE ENDOSCOPE: IF THERE WAS EXCESSIVE BLEEDING DURING THE PATIENT PROCEDURE OR IF PRECLEANING COULD NOT BE PERFORMED IMMEDIATELY AFTER THE PATIENT PROCEDURE, PRESOAKING THE ENDOSCOPE IN DETERGENT SOLUTION BEFORE MANUALLY CLEANING THE ENDOSCOPE MAY BE REQUIRED TO WET AND LOOSEN DEBRIS THAT HAS DRIED AND HARDENED ONTO THE ENDOSCOPE¿S SURFACES. FOLLOW THE PROCEDURE DESCRIBED BELOW. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATES TO SECTIONS E1, E2 AND E3.
CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 16-FEB-2022. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.
A USER FACILITY RETURNED THE OLYMPUS, MODEL GIF-H170, GASTROINTESTINAL VIDEOSCOPE TO OLYMPUS FOR REPAIR DUE TO MULTIPLE PROBLEMS REPORTED. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIAL WAS FOUND EXITING FROM THE AIR/WATER NOZZLE. THIS REPORT IS SUBMITTED DUE TO THE FOREIGN MATERIAL FOUND EXITING THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801711 | GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | FDS | OLYMPUS MEDICAL SYSTEMS CORP. | GIF-H170 | 04953170334115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |