4K UHD Laparoscope
Scivita Medical Technology Co., Ltd. · Model 4K1000L · UDI-DI 06971381251371
Description
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | Olympus Corporation of the Americas | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. |
| 2025-12-11 | Applied Medical Resources Corp | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-06-18 | Stryker Corporation | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2024-06-25 | UNIMAX MEDICAL SYSTEMS INC | The tube may fall into the surgical site during the grasping process. |
| 2024-06-11 | Canadian Hospital Specialties Ltd. | A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint. |
| 2024-06-03 | ASPEN SURGICAL | The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised. |
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