Olympus Thunderbeat Hand Instrument Probe Tips May Break or Detach
Olympus is recalling the Thunderbeat surgical hand instrument because the probe tips are being damaged or breaking. The recall affects 34,325 units distributed in the US and internationally.
What this means for you
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: This is an FDA Class II recall for a surgical instrument with mechanical failures of the probe tips. No injuries or hospitalizations are reported in the source. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Olympus Corporation of the Americas is recalling the Thunderbeat Front-Actuated Grip Type S hand instrument (Model TB-0545FCS). This is a sterile, single-use surgical instrument used with Ultrasonic Generators, Electrosurgical Generators, and Thunderbeat Transducers.
The probe tips of the hand instruments are being damaged or breaking, including pad damage and detachment.
The recall affects 34,325 units: 13,267 in the US and 21,058 internationally. All lot numbers are included. The product has been distributed to the US and over 80 countries including Canada, Europe, Asia, Africa, and the Middle East.
The recalled product
- Product
- Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, sing
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- probe-tip-breakage
- probe-tip-detachment
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 (5)
- Model: TB-0545FCS
- Catalog Number/Product Code: R5000688
- UDI: 04953170409684
- 04953170383519
- Lots: All
Distribution
Distributed nationwide across the United States.
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