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COBRA

Richard Wolf GmbH · Model 7326076 · UDI-DI 04055207013755

FAJ

510(k) clearances

10,639

Adverse events (3 deaths)

Recalls

137

Facilities

Description

FIBER-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.3Fr, working channel 2: 3.3Fr, slanted distal tip Ø 6 Fr, TL 1010mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, glass fiber light cable, fiber image carrier, manual focus

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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Data 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.