Potential for detachment of a distal tip component of the device during use.
Potential for detachment of a distal tip component of the device during use.
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: E-Mail
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Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.. Reason: Potential for detachment of a distal tip component of the device during use.. Classification: Class II. Quantity: 490 units. Distribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
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Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.