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LiNA OperaScope™ with HDMI cable
Lina Medical ApS · Model OP-200-6 · UDI-DI 05708265012374
10
510(k) clearances
8,602
Adverse events (41 deaths)
16
Recalls
134
Facilities
Description
LiNA OperaScope™ with HDMI cable, without on-board LCD screen, intended for hysteroscopy and cystoscopy
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-24 | Olympus Corporation of the Americas | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| 2026-08-24 | Olympus Corporation of the Americas | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| 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. |
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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.