PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 18, 2023 Initiated: September 12, 2023 #Z-0108-2024

Product Description

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, grasping, and dissection is performed

Reason for Recall

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Details

Units Affected
2496 units
Distribution
US Nationwide distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled? ▼
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, grasping, and dissection is performed. Recalled by Olympus Corporation of the Americas. Units affected: 2496 units.
Why was this product recalled? ▼
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0108-2024.

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