MEDIVISION
MEDIVISION, INC. · Model MV1030 · UDI-DI 00851328007154
Description
The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.
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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