FDA Adverse Event
Injury
Summary report: N
OLYMPUS RESECTION SHEATH FOR UROLOGIC
MDR report key: 24405022
·
Received February 20, 2026
Report
- Report Number
- 24405022
- Event Type
- Injury
- Date Received
- February 20, 2026
- Date of Event
- January 22, 2026
- Report Date
- January 26, 2026
- Manufacturer
- LOLYMPUS WINTER AND LBE GMBH
- Product Code
- HIH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING A SCHEDULED UROLOGICAL PROCEDURE, IT WAS OBSERVED THAT THE CERAMIC TIP OF THE RESECTOSCOPE HAD BROKEN OFF AND WAS SEEN IN THE BLADDER. THE TIP REQUIRED SURGICAL INTERVENTION THROUGH INCISION TO REMOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461503 | OLYMPUS RESECTION SHEATH FOR UROLOGIC | RESECTION SHEATH FOR UROLOGIC | HIH | LOLYMPUS WINTER AND LBE GMBH | A22040A | 23Y50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Required Intervention |