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M3 GOLD

Gyrus ACMI, LLC · Model M3-0A · UDI-DI 00821925005648

FAS Prescription

510(k) clearances

2,372

Adverse events (4 deaths)

Recalls

Facilities

Description

M3 Gold Autoclavable Direct Telescope 0 degrees, Color Coded Yellow

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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Data 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.