Olympus Corporation of the Americas recalled 633 units of the Cystoscope Outer Sheath, Model WA22810A on September 13, 2024. The recall occurred due to potential device damage when used with a GreenLight Laser for BPH therapy. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The Olympus Cystoscope Outer Sheath is a medical device used during procedures for benign prostatic hyperplasia (BPH) therapy. Healthcare providers purchase this product to aid in patient treatments effectively.
The device's incompatibility with the GreenLight Laser can lead to damage at the tip, affecting its functionality during medical use. This can potentially endanger patient safety during procedures.
This recall is not part of a broader industry pattern.
Patients using this device may experience delays in treatment due to the recall. Immediate action is necessary to prevent possible complications during medical procedures.
The model number can typically be found on the packaging or the device itself, usually near the handle or base.
Expect processing for refunds or replacements to take about 4-6 weeks after submission.
Keep all correspondence related to the recall. Document any issues encountered with the device for future reference.
The recalled product is the Olympus Cystoscope Outer Sheath, Model WA22810A. All lots of this model are affected. The device was distributed nationwide in the United States.
Not sure what to do next? Our guide walks you through the process step by step.
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