Device product
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-201 2. Single Use Guide Sheath Kit K-202 2.0MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-202 3. Single Use Guide Sheath Kit K-203 2.6MM Channel Set: Guide Sheath, Biopsy Forceps, Cytology Brush; Model Number: K-203 4. Single Use Guide Sheath Kit K-204 2.6MM Channel Set: Guide Sheath, Biopsy Forceps; Model Number: K-204. Used to collect cells or tissue specimens in the respiratory organs.
Z-1071-2025
Product summary
- Event
- Event 96087
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 454 units
- Official record key
device-enforcement:Z-1071-2025
Official wording
Reason: Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Code information: 1. Model Number: K-201; UDI-DI: 04953170245466; All Lots. 2. Model Number: K-202; UDI-DI: 04953170245480; All Lots 3. Model Number: K-203; UDI-DI: 04953170245503; All Lots 4. Model Number: K-204; UDI-DI: 04953170245527; All Lots
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.