Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage
Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. This is a risk-of-harm product where injury has not yet been reported, per the rubric's Score 3 criterion.
Plain-English summary
Olympus Corporation of the Americas has recalled 738 units of the Cystoscope Outer Sheath (Model WA22810A) distributed nationwide due to the potential for a damaged probe tip during use with GreenLight Laser for BPH therapy.
The company identified that the outer sheath could be damaged when used with the GreenLight Laser probe, which could affect the device's proper function. To address this, Olympus has updated the Instruction for Use (IFU) to remove the statement of compatibility with the GreenLight Laser for BPH therapy.
Healthcare facilities and providers in possession of this model should review the updated instructions. No illnesses or injuries have been reported.
The recalled product
- Product
- Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 738
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model: WA2280A
- UDI: 04042761051729
- Lot#: All lots.
Distribution
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