Device product

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Z-1437-2026

September 13, 2024

Class II

Product summary

Firm: Olympus Corporation of the Americas
Event: Event 98300
Status: Ongoing
Classification: Class II
Quantity: 633 units
Official record key: device-enforcement:Z-1437-2026

Official wording

Reason: Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

Code information: Model: WA2280A; UDI: 04042761051729; Lot#: All lots;

Distribution pattern: Distribution US nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.