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Accessory for urology
SOPRO-COMEG GmbH · Model 395 410 017BC · UDI-DI 04059082026596
1
510(k) clearances
10,639
Adverse events (3 deaths)
22
Recalls
137
Facilities
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.