Gyrus Acmi, Inc
FDA adverse event reports naming Gyrus Acmi, Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GYRUS ACMI, INC.
- Total reports
- 1,540
- Deaths
- 2
- Injuries
- 225
- Malfunctions
- 1,308
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI621
- Powered Laser Surgical InstrumentGEX164
- Hysteroscope (And Accessories)HIH93
- Lithotriptor, UltrasonicFEO83
- Bronchoscope AccessoryKTI62
- Electrode, Electrosurgical, Active, UrologicalFAS57
- Dilator, EsophagealKNQ37
- Bur, Ear, Nose And ThroatEQJ35
- Laparoscopic Contraceptive Tubal Occlusion DeviceKNH32
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS30
Recent recalls
- 2018-03-20Open, Classified
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
"Chattering" when cutting burrs are used in bone.
- TerminatedSoftware design
Olympus Diego Elite Console MDCONS 100
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- TerminatedSoftware design
Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
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