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Single Use Flexible Video Cystoscope

Zhuhai Pusen Medical Technology Co, Ltd · Model PC200-R · UDI-DI 06971176280357

FAJ Prescription

510(k) clearances

10,639

Adverse events (3 deaths)

Recalls

137

Facilities

Description

This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.

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.