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MEDIVISION
MEDIVISION, INC. · Model MV2930 · UDI-DI 00851328007185
10
510(k) clearances
11,196
Adverse events (3 deaths)
22
Recalls
137
Facilities
Description
CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. HYSTEROSCOPE MediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 2023-12-04 | Shirakawa Olympus Co., Ltd. | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| 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 |
| 2022-05-03 | Karl Storz Endoscopy | The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue. |
| 2022-04-20 | Olympus Corporation of the Americas | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of |
| 2022-04-01 | Karl Storz Endoscopy | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
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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.