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Gyrus ACMI
Gyrus ACMI, LLC · Model 257F6 · UDI-DI 00821925004283
FAS
Prescription
1
510(k) clearances
2,372
Adverse events (4 deaths)
9
Recalls
68
Facilities
Description
Fulgurating Electrode, Ball Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-02 | Olympus Corporation of the Americas | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. |
| 2023-06-08 | Olympus Corporation of the Americas | Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, s |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2018-04-17 | Gyrus Acmi, Incorporated | There is a potential for the cord to spark and cause a fire. |
| 2016-11-03 | Olympus Corporation of the Americas | Software malfunction that results in incorrect generation or display of error codes. |
| 2016-10-12 | C.R. Bard, Inc. | Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.