EVIS EXERA III DUODENOVIDEOSCOPE
Report
- Report Number
- 8010047-2022-03213
- Event Type
- Injury
- Date Received
- February 18, 2022
- Report Date
- April 26, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDT
- UDI-DI
- 04953170405563
- PMA / PMN Number
- K202661
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. 510K: K193182. THE OLYMPUS SERVICE CENTER DID NOT CONFIRM A BROKEN PIECE OF THE STENT IN THE SCOPE. THE EVALUATION ALSO FOUND THE FOLLOWING: LEAK FROM BIOPSY CHANNEL, INSERTION TUBE INSULATION ISSUE, PUNCTURE IN CHANNEL, CONTROL KNOBS PLAY, DENTS AND SCRATCHES ON DISTAL END COVER, GLUE IS PEELING AROUND LIGHT GUIDE LENS, BENDING SECTION RUBBER GLUE IS PEELING AND DEEP SCRATCHES ON INSERTION TUBE AT 80 AND 60 MARK. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.
THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. 510K: K193182. THE OLYMPUS SERVICE CENTER DID NOT CONFIRM A BROKEN PIECE OF THE STENT IN THE SCOPE. THE EVALUATION ALSO FOUND THE FOLLOWING: LEAK FROM BIOPSY CHANNEL, INSERTION TUBE INSULATION ISSUE, PUNCTURE IN CHANNEL, CONTROL KNOBS PLAY, DENTS AND SCRATCHES ON DISTAL END COVER, GLUE IS PEELING AROUND LIGHT GUIDE LENS, BENDING SECTION RUBBER GLUE IS PEELING AND DEEP SCRATCHES ON INSERTION TUBE AT 80 AND 60 MARK. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS LIKELY DUE TO THE BIOPSY CHANNEL WAS EXCESSIVELY STRESSED BECAUSE THE CHANNEL WAS PERFORATED AND ALSO LEAKED. SINCE THE STENT USED WAS NON-OLYMPUS, WE COULD NOT CONFIRM THE USAGE, PRECAUTIONS, AND COMPATIBILITY AND IT WAS DIFFICULT TO CONSIDER. WE WOULD LIKE THE USER FACILITY TO CONFIRM THE USAGE, PRECAUTIONS, AND COMPATIBILITY TO BOSTON SCIENTIFIC. AS STATED IN THE INSTRUCTIONS FOR USE OF STENT PRODUCED BY OLYMPUS DESCRIBES PRECAUTIONS FOR USE AS FOLLOWS: OPERATION WARNING- WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE, RAISE THE FORCEPS ELEVATOR TO ITS MAXIMUM HEIGHT. IF THE FORCEPS ELEVATOR IS DOWN, YOU WILL NOT BE ABLE TO SEE THE DISTAL END OF THE INSERTION PORTION IN THE ENDOSCOPIC FIELD OF VIEW. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. DO NOT FORCE THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGULATION OR LOWER THE FORCEPS ELEVATOR UNTIL THE INSTRUMENT PASSES SMOOTHLY. DO NOT ADVANCE OR EXTEND THE INSTRUMENT ABRUPTLY. THESE ACTIONS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE, AND COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. DO NOT INSERT THE INSTRUMENT AND/OR INSERTION KIT INTO THE ENDOSCOPE UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. IF YOU CANNOT SEE THE DISTAL END OF THE INSTRUMENT AND/OR INSERTION KIT IN THE ENDOSCOPIC FIELD OF VIEW OR IN X-RAY IMAGES, DO NOT USE IT. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. DO NOT FORCE THE DISTAL END OF THE INSTRUMENT AGAINST BODY CAVITY. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IF THIS INSTRUMENT IS BROKEN IN THE BODY, COLLECT ANY PIECE OF THE INSTRUMENT LEFT IN THE BILE DUCT WITH GRASPING FORCEPS OBSERVING X-RAY. IF SUCH A PIECE FALLS OFF IN THE DUODENUM, COLLECT IT WITH GRASPING FORCEPS, TOO. RETRIEVAL OF THE STENT: WARNING - WHEN WITHDRAWING THIS INSTRUMENT, CONFIRM UNDER X-RAY THAT THE INSERTED PART OF IT IS FREE FROM KINKS AND IS NOT STUCK IN THE STRICTURE. OTHERWISE, IT COULD CAUSE PATIENT INJURY, SUCH AS MIGRATION AND DISLOCATION OF THE STENT. WHEN RETRIEVING THIS INSTRUMENT FROM THE BILE DUCT, GRASP A PART AVOIDING THE VICINITY OF SIDE HOLE OR SIDE FLAP AS MUCH AS POSSIBLE, AND SLOWLY ALIGNED WITH BILE DUCT WITHDRAW IT WITH THE ENDOSCOPE OBSERVING FLUOROSCOPIC IMAGES. IF A PART AROUND THE SIDE HOLE OR SIDE FLAP IS STRONGLY GRASPED BY A SNARE OR GRASPING FORCEPS, OR THE STENT IS WITHDRAWN WITH EXCESSIVE FORCE, THIS INSTRUMENT MAY BREAK AND LEAVE DEBRIS IN THE BILE DUCT. DO NOT RETRIEVE THIS INSTRUMENT IN OTHER METHODS THAN DESCRIBED IN THIS INSTRUCTION MANUAL. OTHERWISE, IT COULD CAUSE MIGRATING OR FALLING OFF FROM THE PAPILLA AND COULD DAMAGE THE INSTRUMENT. CAUTION DO NOT USE THE INSTRUMENT THAT HAS BEEN INSERTED INTO THE ENDOSCOPE. INSTRUMENT DAMAGE MAY OCCUR. DO NOT COLLECT THE STENT THROUGH THE CHANNEL OF THE ENDOSCOPE. INSTRUMENT DAMAGE MAY OCCUR.
THE CUSTOMER REPORTED TO OLYMPUS, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE A STENT, A PIECE OF THE STENT BROKE OFF INSIDE THE SUBJECT DEVICE WORKING CHANNEL. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE OLYMPUS SERVICE DEPARTMENT DID NOT IDENTIFY A BROKEN PIECE OF THE STENT INSIDE THE WORKING CHANNEL. THE CUSTOMER WAS INFORMED. THE CUSTOMER STATED IT IS POSSIBLE THE BROKEN STENT FLOATED DOWN THE DUODENUM AND WAS NOT VISUALIZED. THIS IS A REPORTABLE EVENT.
THE CUSTOMER REPORTED TO OLYMPUS, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE A STENT, A PIECE OF THE STENT BROKE OFF INSIDE THE SUBJECT DEVICE WORKING CHANNEL. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE OLYMPUS SERVICE DEPARTMENT DID NOT IDENTIFY A BROKEN PIECE OF THE STENT INSIDE THE WORKING CHANNEL. THE CUSTOMER WAS INFORMED. THE CUSTOMER STATED IT IS POSSIBLE THE BROKEN STENT FLOATED DOWN THE DUODENUM AND WAS NOT VISUALIZED. THIS IS A REPORTABLE EVENT.
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE BROKEN STENT WAS NOT AN OLYMPUS DEVICE. THE PATIENT'S HEALTH STATUS TODAY IS UNKNOWN. IT IS UNKNOW IF ANY INTERVENTION OR CHANGE IN TREATMENT COURSE WAS REQUIRED DUE TO THE BROKEN STENT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1231518 | EVIS EXERA III DUODENOVIDEOSCOPE | DUODENOVIDEOSCOPE | FDT | OLYMPUS MEDICAL SYSTEMS CORP. | TJF-Q190V | 04953170405563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other | UNKNOWN STENT. |