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Gyrus ACMI
Gyrus ACMI, LLC · Model 714750 · UDI-DI 00821925009141
FDS
Prescription
1
510(k) clearances
73,274
Adverse events (53 deaths)
12
Recalls
68
Facilities
Description
RESECTOSCOPE, 24 FR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Olympus Corporation of the Americas | High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from |
| 2024-09-18 | Olympus Corporation of the Americas | To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2023-07-27 | Aomori Olympus Co., Ltd. | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002 |
| 2022-04-22 | Olympus Corporation of the Americas | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections |
| 2017-02-17 | Fujifilm Medical Systems U.S.A., Inc. | Fujifilm is recalling multiple endoscopes after a retrospective review. |
| 2016-08-15 | Pentax of America Inc | PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs. |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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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.