China NMPA Product Recall - Cystoscopic accessories

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of certain cystoscope accessories, as announced by the National Medical Products Administration (NMPA) on August 29, 2017. The core issue driving this recall is the potential for adhesive detachment within the connecting bridge tubing of the product. This defect could compromise the device's performance and safety during medical procedures. The affected cystoscope accessories are identified by Registration No. 20153223595. While specific inspection dates are not detailed in the provided document, the recall was a proactive measure undertaken by Olympus Trading (Shanghai) Co., Ltd. to address the manufacturing concern. This action falls under the regulatory framework of the NMPA, which oversees medical device safety in China. The required action involves the recall of the impacted products, with detailed information on models, specifications, and batch numbers available in the attached "Medical Device Recall Event Report Form" submitted during the process. This highlights the company's commitment to ensuring product integrity and patient safety under NMPA's guidance.