Olympus Recalls Thunderbeat Surgical Instruments Due to Component Damage
Olympus America Inc. is recalling Thunderbeat surgical instruments because they may crack, break, or deform during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device with reported mechanical failures (cracking, breaking) during surgery, which poses a risk of harm to patients, but no specific injuries or fatalities are reported in the source text.
Plain-English summary
Olympus America Inc. is recalling specific models of the Thunderbeat Surgical Tissue Management System. The affected products include various Thunderbeat hand instruments with 5 mm tips in pistol grip, inline grip, and front actuated grip configurations, with lengths ranging from 10 mm to 45 mm.
The recall was initiated due to complaints of damage to the instruments during surgical procedures. Reported issues include cracking, breaking, or deformation of the components of the probe tip or jaw. These instruments are intended for use in open, laparoscopic, and endoscopic surgery to cut, coagulate, or ligate soft tissue and vessels.
The recall covers 8,709 units that were distributed nationwide in the United States, including Puerto Rico, as well as internationally to Canada. Consumers and healthcare facilities should stop using the affected devices and contact Olympus America Inc. for further instructions.
The recalled product
- Product
- TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0…
- Manufacturer
- Olympus America Inc.
- Affected units
- 8,709
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 (1)
- All sold units
Distribution
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