Recall Z-0109-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0109-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-12

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-09-12. It names one FDA 510(k) clearance: K211838. Product: THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS 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: 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.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-09-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K211838 — Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation·cleared 2021-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.