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USA Elite System
Gyrus ACMI, LLC · Model EOS-HCF27 · UDI-DI 00821925002104
HIH
Prescription
1
510(k) clearances
8,394
Adverse events (41 deaths)
14
Recalls
134
Facilities
Description
USA Elite System Continuous Flow Resectoscope Outer Sheath, Round Tip 27.6 Fr, (9.2 mm) Color Coded White
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Karl Storz Endoscopy | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| 2024-04-18 | Olympus Corporation of the Americas | The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-07-20 | Olympus Corporation of the Americas | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. |
| 2023-06-23 | Scholly Fiberoptic Gmbh | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occu |
| 2022-06-07 | Covidien Llc | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
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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.