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4K UHD Camera System
Scivita Medical Technology Co., Ltd. · Model ES-CS4K100/100C · UDI-DI 06971381250060
1
510(k) clearances
17,255
Adverse events (24 deaths)
19
Recalls
151
Facilities
Description
The product is composed of a 4K camera control unit, a 4K camera head, objective lens, a power cable, and video cables. Video cables contains: HD-SDI cable, HDMI cable. HD-SDI cable, HDMI cable and objective lens are optional. 4K UHD Camera System is mainly used to provide imaging of the operative area in endoscopic surgery. Do not use this system for any other purpose.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-27 | Karl Storz Endoscopy | Inadequate reprocessing validation evidence |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-20 | Olympus Corporation of the Americas | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocess |
| 2023-11-06 | Olympus Corporation of the Americas | Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual |
| 2023-10-24 | Karl Storz Endoscopy | The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the pa |
| 2022-02-23 | Carefusion 2200 Inc | The finished device package did not contain the IFU. |
| 2017-02-10 | Olympus Corporation of the Americas | A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot. |
| 2015-11-17 | Olympus Corporation of the Americas | A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury. |
| 2014-07-16 | Market-Tiers Inc | Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. |
| 2009-09-28 | Ethicon, Inc. | There is the potential for the duckbill seal to become dislodged. |
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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.