HIGH

Olympus Cystoscope Outer Sheath Recalled Over Laser Incompatibility

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.

Quick Facts at a Glance

Recall Date
September 13, 2024
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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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About This Product

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.

Why This Is Dangerous

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.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients using this device may experience delays in treatment due to the recall. Immediate action is necessary to prevent possible complications during medical procedures.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number on the device. It should read WA22810A.
  2. Check for any notification letters from Olympus Corporation regarding the recall.
  3. Consult with your healthcare provider to confirm if your device is affected.

Where to find product info

The model number can typically be found on the packaging or the device itself, usually near the handle or base.

What timeline to expect

Expect processing for refunds or replacements to take about 4-6 weeks after submission.

If the manufacturer is unresponsive

  • Document your communications with Olympus Corporation.
  • Reach out to your healthcare provider for assistance.
  • Consider filing a complaint with the FDA if you receive no response.

How to prevent similar issues

  • Always check for recalls before using medical devices.
  • Consult with healthcare providers about device compatibility.
  • Ensure the device has proper safety certifications.

Documentation advice

Keep all correspondence related to the recall. Document any issues encountered with the device for future reference.

Product Details

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.

Key Facts

  • Recall date: September 13, 2024
  • Model: WA22810A
  • Quantity recalled: 633 units
  • Distribution: Nationwide in the United States

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Model: WA2280A
UDI: 04042761051729
Lot#: All lots
Affected States
ALL
Report Date
March 4, 2026
Recall Status
ACTIVE

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