# China NMPA Product Recall - OES fiber optic cystoscope; electronic cystoscope; electronic cystoscope; fiber optic cystourethroscope; flexible cystourethroscope; fiber optic cystourethroscope; electronic endoscope; electronic cystourethroscope; OES fiber optic ureteroscope; fiber optic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic choledochoscope (trade name: LUCERA); OES fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; choledochoscope; electronic choledochoscope; fiber hysteroscope; electronic choledochoscope (trade name: EVIS LUCERA); fiber optic hysteroscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/044b98ad-f3ff-4faf-be04-9a6080cadec7/
Source feed: China

> China NMPA product recall for OES fiber optic cystoscope; electronic cystoscope; electronic cystoscope; fiber optic cystourethroscope; flexible cystourethroscope; fiber optic cystourethroscope; electronic endoscope; electronic cystourethroscope; OES fiber optic ureteroscope; fiber optic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic choledochoscope (trade name: LUCERA); OES fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; choledochoscope; electronic choledochoscope; fiber hysteroscope; electronic choledochoscope (trade name: EVIS LUCERA); fiber optic hysteroscope by Olympus Trading (Shanghai) Co., Ltd. published July 06, 2021. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall on July 6, 2021, for a br

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling OES fiber optic cystoscopes; electronic cystoscopes; flexible cystourethroscopes; fiber optic cystourethroscopes; electronic cystourethroscopes; OES fiber optic ureteroscopes; fiber optic ureteroscopic endoscopes; electronic ureteroscopic endoscopes; electronic ureteroscopic endoscopes; electronic ureteroscopic endoscopes; electronic cholangioscopes (trade name: EVIS LUCERA); OES fiber optic cholangioscopes; fiber optic cholangioscopes; fiber optic cholangioscopes; fiber optic cholangioscopes; electronic cholangioscopes; fiber hysteroscopes).
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-07-06
- Product Name: OES fiber optic cystoscope; electronic cystoscope; electronic cystoscope; fiber optic cystourethroscope; flexible cystourethroscope; fiber optic cystourethroscope; electronic endoscope; electronic cystourethroscope; OES fiber optic ureteroscope; fiber optic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic ureteropelvic endoscope; electronic choledochoscope (trade name: LUCERA); OES fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; fiber optic choledochoscope; choledochoscope; electronic choledochoscope; fiber hysteroscope; electronic choledochoscope (trade name: EVIS LUCERA); fiber optic hysteroscope
- Recall Level: Level 2 Recall
- Recall Reason: An FDA investigation into product-related infection complaints revealed that between January 2016 and March 2021, a total of 171 infection complaints from 38 hospitals involved Olympus cystoscopes (CYF series), Olympus ureteroscopes (URF series), and the MAJ-891 forceps/irrigation plug (insulated type). In 73 of these complaints, it was confirmed that the hospitals' reprocessing procedures for the MAJ-891 deviated from the reprocessing methods provided by Olympus.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall on July 6, 2021, for a broad spectrum of its OES fiber optic and electronic endoscopes, including various cystoscopes, ureteroscopes, cholangioscopes, and hysteroscopes, along with the MAJ-891 forceps/irrigation plug. This action was prompted by an investigation overseen by the Shanghai Municipal Drug Administration, operating under the regulatory framework of China's National Medical Products Administration (NMPA). The recall addresses 171 infection complaints reported by 38 hospitals between January 2016 and March 2021. A significant finding revealed that in 73 of these instances, hospitals were not adhering to Olympus's specified reprocessing procedures for the MAJ-891 component, indicating a potential discrepancy in instruction clarity or user compliance. Olympus is actively seeking clarification on its affected products as part of this recall. Detailed information regarding specific product models, specifications, and batches is provided in the associated "Medical Device Recall Event Report Form," outlining the required actions to mitigate patient safety risks associated with these devices.

Company: https://www.globalkeysolutions.net/companies/olympus-trading-shanghai-co-ltd/510963e8-8b01-4884-b017-bc21b376ca33/