Question 1

Is THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.
Model: TB-0535FCS
Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, gra recalled?

Accepted Answer

Olympus Corporation of the Americas is recalling 2,767 Thunderbeat surgical instruments because the blue seal button may get stuck in the engaged position rather than returning to neutral when released. This defect involves two models of the Thunderbeat Front-actuated Grip Type S used in various abdominal, gynecological, and thoracic surgeries. If the button sticks, it can lead to unintended continuous activation or device malfunction, which may cause prolonged surgery times for patients.

Question 2

What should I do?

Accepted Answer

Identify if you have the affected THUNDERBEAT 5MM Front-actuated Grip Type S devices by checking the model and lot numbers on the packaging. For the 35CM model (TB-0535FCS), check for UDI-DI 4953170409677 and lot numbers including KR271978, KR314612, KR314613, KR314615, KR314617, KR314618, KR314619, KR314621, KR314622, KR314623, KR314624, KR314626, KR314627, KR314628, KR314629, KR314630, KR314631, KR314632, KR314633, KR314634, KR314638, KR314640, KR314641, KR314644, KR314647, KR314648, KR314650, KR314651, KR314652, KR314654, KR314655, KR314657, KR314659, KR314660, KR314662, KR314663, KR314668, KR314670, KR314671, KR314672, KR314673, KR314674, KR314675, KR314676, KR314679, KR316617, KR316627, KR316629, KR316637, KR316683, KR319616, KR319643, KR319655, KR332609, KR332615, KR332616, KR332623, KR332626, KR335733, KR335754, KR335760, KR335769, KR335770, KR335776, KR335781, KR335784, KR335785, KR335794, KR335796, KR335836, PW308606, PW308607, PW308609, PW308611, PW308613, PW308615, PW308616, PW308663, PW308772, PW308773, PW308774, PW308775, PW308776, PW308786, PW308788, and KR342666. For the 45CM model (TB-0545FCS), check for UDI-DI 4953170409684 and lot numbers KR310806, KR310809, KR313734, KR319658, KR326619, KR326628, KR333661, and KR342666. Immediately stop using any affected surgical devices and quarantine them to prevent use in upcoming procedures. Contact your healthcare provider or Olympus Corporation of the Americas for instructions on how to return the affected units and obtain a potential refund or replacement. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or the manufacturer for further instructions and potential refund

Olympus Corporation of the Americas: Thunderbeat Surgical Devices Recalled for Sticking Buttons

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information

Were You Affected by This Recall?