URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL
Report
- Report Number
- 9610773-2026-00609
- Event Type
- Malfunction
- Date Received
- January 29, 2026
- Report Date
- March 30, 2026
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- FGB
- UDI-DI
- 04042761086387
- PMA / PMN Number
- K200369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 501
Narratives
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H4, H6, H11. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE "URETROSCOPE TIP LENS COME OUT" WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
IT WAS REPORTED THAT THE RIGID URETEROSCOPE HAD ITS LENS CAME OUT DURING INSPECTION FOR USE. THE WAS NO PATIENT HARM.
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272332 | URETEROSCOPE 6.7/8.4 FR. X 430 MM, 5°, ANGLED OCULAR, 4.2 FR. CHANNEL | RIGID URETEROSCOPE | FGB | OLYMPUS WINTER & IBE GMBH | WA2UR11A | 04042761086387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |