Olympus Corporation of the Americas is recalling approximately 107,162 Thunderbeat surgical instruments due to a continued number of reported adverse events. These devices are used in surgical procedures to cut tissue and seal blood vessels using a combination of ultrasonic and advanced bipolar energy. While the specific nature of the adverse events was not detailed in the notice, the firm is initiating a removal to ensure patient safety.
The continued reports of adverse events suggest a potential failure in device performance or safety during surgical procedures, which could lead to surgical complications or injury to patients. No specific injury counts were provided in this update, but the recall is classified as a medium risk removal.
9,542 units affected.
88,268 units affected.
4,181 units affected.
0 units affected in this specific distribution lot.
0 units affected in this specific distribution lot.
0 units affected in this specific distribution lot.
30 units affected.
3,381 units affected.
30 units affected.
52 units affected.
140 units affected.
1,538 units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES ยท Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.