EVIS LUCERA ULTRATHIN VIDEOSCOPE
Report
- Report Number
- 9610595-2025-01088
- Event Type
- Injury
- Date Received
- February 4, 2025
- Date of Event
- December 23, 2024
- Report Date
- April 15, 2025
- Manufacturer
- AIZU OLYMPUS CO., LTD.
- Product Code
- FBN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: H6. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARATIVE STUDY OF THERAPEUTIC OUTCOMES IN PATIENTS WHO DEVELOPED HEPATOLITHIASIS AFTER HEPATICOJEJUNOSTOMY: BALLOON-ASSISTED ENTEROSCOPIC APPROACH VERSUS PERCUTANEOUS TRANSHEPATIC APPROACH." BACKGROUND: THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WHO UNDERWENT HEPATICOJEJUNOSTOMY (HJS) IS CHALLENGING. IN THIS STUDY, WE AIMED TO CLARIFY THE THERAPEUTIC OUTCOMES OF DOUBLE BALLOON ENTEROSCOPY (DBE) AND PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) FOR HEPATOLITHIASIS AFTER HJS. METHODS: PATIENTS WHO UNDERWENT DBE OR PTBD FOR HEPATOLITHIASIS AFTER HJS AT HIROSHIMA UNIVERSITY HOSPITAL WERE ENROLLED, AND TREATMENT OUTCOMES AND RECURRENCE WERE COMPARED. RESULTS: FORTY-EIGHT OF THE 84 ELIGIBLE PATIENTS UNDERWENT DBE, WITH THE HJS SITE REACHED IN 42 PATIENTS (87.5%; DBE GROUP). FORTY-ONE PATIENTS UNDERWENT PTBD (PTBD GROUP). THERE WERE NO DIFFERENCES IN THE CLINICAL CHARACTERISTICS AND STONE-RELATED FACTORS, INCLUDING LOCALIZATION, MAXIMUM DIAMETER, AND QUANTITY, BETWEEN BOTH GROUPS. THE COMPLETE STONE REMOVAL RATES IN THE DBE AND PTBD GROUPS WERE (B)(4), RESPECTIVELY. THE DBE GROUP HAD A SIGNIFICANTLY SHORTER MEDIAN LENGTH OF HOSPITAL STAY THAN THE PTBD GROUP (6 VS. 21 DAYS, P < 0.001). DURING A MEDIAN FOLLOW-UP OF 45 MONTHS, STONE RECURRENCE WAS OBSERVED IN 22 (32.8%) PATIENTS. THE CUMULATIVE RECURRENCE RATES AT 1, 3, 5, AND 10 YEARS WERE 13.1%, 31.8%, 34.9%, AND 52.7%, RESPECTIVELY. THE STONE RECURRENCE RATES OF THE DBE AND PTBD GROUPS WERE NOT SIGNIFICANTLY DIFFERENT (28.6% VS.37.5%). MULTIVARIATE ANALYSIS REVEALED A STONE DIAMETER > 8 MM (HAZARD RATIO, 2.602; P = 0.026) AND AGE = 70 YEARS (HAZARD RATIO, 3.077; P = 0.017) AS INDEPENDENT RISK FACTORS FOR STONE RECURRENCE. CONCLUSIONS: DBE SHOWED OUTCOMES COMPARABLE TO THOSE OF PTBD IN THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WHO UNDERWENT HJS. ALTHOUGH REACHING THE HJS SITE IS DIFFICULT IN SOME CASES, TREATMENT CAN BE COMPLETED WITHIN A SHORT PERIOD WITH DBE; THEREFORE, IT COULD BE THE FIRST CHOICE OF TREATMENT FOR HEPATOLITHIASIS AFTER HJS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. MILD ACUTE CHOLANGITIS REQUIRING ANTIBIOTIC TREATMENT = 6 PATIENTS (DBE GROUP) MILD ACUTE CHOLANGITIS REQUIRING ANTIBIOTIC TREATMENT = 12 PATIENTS (PTBD GROUP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 62023 | EVIS LUCERA ULTRATHIN VIDEOSCOPE | CHOLEDOCHO FIBERSCOPE | FBN | AIZU OLYMPUS CO., LTD. | CHF-BP260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | .025 INCH GUIDEWIRE| 6-10 MM BALLOON DILATION CATHETER| BASKET CATHETER| ELECTROHYDRAULIC LITHOTRIPSY SYSTEM| ENDOSCOPIC NASOBILIARY DRAINAGE CATHETER| ERCP CANNULA| MECHANICAL LITHOTRIPTER| RETRIEVAL BALLOON CATHETER |