**: The home of the instrument, unauthorized shall not **, and 24 hours later**.
Recently, the FDA's official website announced that the recall of Olympus' bronchofiberscope and bronchoscope was determined to be a first-degree recall, due to the series of devices that may cause burns and fires, and the possibility of fatal events. At present, there have been 192 complaints about related product problems, of which 4 people have been injured.
It is important to note that this recall is a correction, not a product removal. Currently, the number of recalls of this device in the United States is 17,691 units, involving products distributed between January 1, 2001 and September 11, 2023.
In fact, since 2023, Olympus has initiated multiple recalls as well. As a global endoscope giant, its frequent product failures and quality control problems have aroused special attention in the industry.
Identified by the FDA as a Level 1 recall
Bronchoscopy is used for endoscopic diagnosis of the pulmonary airways and**. Bronchofiberscopes and thoracic tubescopes are tube-like devices that can be used with accessories such as cameras and lamps to examine or ** a person's airway.
Screenshot from the FDA official website.
The use of an affected bronchoscope may result in serious adverse health consequences, including severe burns to the person's airways or lungs, airway bleeding, difficulty breathing, apnea, loss of consciousness, or death. Injuries can result in prolonged surgery, additional medical care, extended hospital stays, ICU care, and death.
There is a risk of burning if high-frequency cauterization is performed at the same time as oxygen is supplied, or if the electrode part of the electrosurgical attachment is too close to the end of the endoscope. Burning can damage or destroy parts of the device that may injure or inadvertently remain in the patient's body and may require retrieval or surgical removal.
On October 12, 2023, Olympus sent an Emergency Medical Device Corrective Action to all affected customers, asking customers to review the warning section of the equipment operation manual, specifically: stop high-frequency cauterization while oxygen is supplied;Electrosurgical equipment used with endoscopes is kept at a sufficient distance from the endoscope;Only use high-frequency devices that are compatible with the Olympus bronchoscope as listed in the operator's manual.
The specific product models involved in this recall are as follows:
Frequent recalls
Involving the domestic market
It is worth noting that since 2023, Olympus has had multiple large-scale recalls.
In November, Olympus announced a voluntary corrective action after receiving four adverse event complaints of serious injuries from patients. According to the FDA's official website, the recall involves nearly 68,000 devices, and 28 BF series bronchoendoscopes worldwide are affected by this error correction action, of which 15 are sold in the United States.
At the end of October this year, the FDA announced that it had classified the high-flow abdominal insufflation device recalled by Olympus as a Level 1 recall, and it is reported that the device has caused 21 malfunctions, 10 serious injuries, and one death due to overinflation. The number of products in this recall is high at 3,136 units.
In addition, according to incomplete statistics, Olympus has also carried out several recalls in the Chinese market this year.
November
On November 1, the official website of the State Food and Drug Administration released recall information, including two secondary recalls initiated by Olympus.
1.Olympus (Shanghai) reported that due to the wrong suction volume specification of the product inspection card in question, the manufacturer Olympus Medical Co., Ltd. voluntarily recalled the fiber endotracheal intubation endoscope (National Machinery Injection 20142065689) it produced. The recall level is a Level 2 recall.
2.Olympus (Shanghai) reported that due to improper maintenance of the product involved and other reasons, the manufacturer Olympus Medical Co., Ltd. voluntarily recalled the electronic upper gastrointestinal endoscope (National Machinery Injection 20153063036) it produced. The recall level is a Level 2 recall.
October
On October 7, the official website of the State Food and Drug Administration released information that Olympus (Shanghai) reported that due to the unqualified handling of some of the handles provided by the manufacturer, Olympus Medical Co., Ltd., voluntarily recalled the disposable bipolar high-frequency ultrasound dual-output surgical instrument (Sinodevice Injection 20203010020) produced by it. The recall level is a Level 2 recall.
August
According to the official website of the State Drug Administration in August this year, Olympus ** (Shanghai)** reported that due to the wrong description of the Japanese instructions and other reasons, the manufacturer Olympus Weiyinte and Yibei Company have made pediatric urological endoscopes and accessories Pediatric Urologies Telescopes & Accessories (National Machinery Injection 20163063084), high-frequency resection electrodes (National Machinery Injection 20153011433, National Machinery Injection 20193011622) voluntary recall. The recall level is a Level 2 recall.
July
In July this year, Olympus (Shanghai) reported that due to the lack of final inspection standards for some products, the manufacturer Olympus Medical Co., Ltd. made a significant impact on the electronic gastroscope (No. 3220572 of 2012 and No. 3221990 of 2013 of the National Food and Drug Administration), the 20172067070 of the electronic colonoscope and the electronic colonoscope (No. 3220852 of 2012, National Food and Drug Administration (Enter) Word 2013 No. 3224358), Electronic Duodenoscopy (National Food and Drug Administration (Enter) Word 2011 No. 3222826), Electronic Upper Gastrointestinal Endoscope (National Machinery Injection 20153063036, National Machinery Injection 20183062529), Electronic Duodenoscopy Duodenal Intestine Injection 20163063273) voluntarily recalled. The recall level is ** recall.
Retired in Hong Kong
On November 5, 2023, the Hong Kong Hospital Authority issued a notice requiring public hospitals to immediately deactivate 142 Olympus pneumoperitoneum machines.
As a result, it is estimated that about 30 non-urgent laparoscopic minimally invasive surgeries that have been booked at Tuen Mun Hospital, Pok Oi Hospital and Caritas Hospital will need to be rescheduled in the coming week.
This discontinuation notice is affected by a recent FDA-sponsored Level 1 recall. In October this year, the FDA's official website showed that Olympus had launched a Level 1 recall of the UHI-4 high-flow pneumoperitoneum machine.
According to verification, UHI-4 is also sold in China, and was approved in China in May 2021, and is one of the common pneumoperitoneum machine models on the market.
A number of actions have attracted the attention of the industry
As a global endoscopy giant, Olympus's various moves have attracted attention.
Recently, the FDA announced that the recall of bronchofiberscopes and bronchoscopes is a Level 1 recall, and Olympus USA also announced a personnel change, announcing the appointment of Neil Boyden Tanner as Global General Counsel, reporting to President and CEO Stefan Kaufmann.
neil boyden tanner
It is reported that Neil Boyden Tanner will join the company on January 8, 2024 in order to succeed Donna Miller, who will retire at the end of this month, and officially take over as global legal counsel on April 1, 2024.
In terms of business layout, Olympus announced in December that it will establish a new cooperation with Sony in the field of medical devices, especially endoscopes.
The two companies first partnered in September 2012, and the following year Sony owned 51 percent and Olympus 49 percent established a joint venture, Sony Olympus Medical Solutions Inc）。As a result of this collaboration, three products have been launched, including the world's first 4K surgical endoscope system.
The two companies now seek to further expand their collaboration to develop next-generation gastrointestinal and respiratory endoscopes, with a focus on enhancing software development capabilities, in addition to the joint development of 4K (or above) resolution or 3D surgical endoscopes covered by the 2012 agreement.
Despite the product issues, the century-old imaging company is still in a leading position in the industry.
According to public information, Olympus, founded in 1919, has developed into the world's leading medical technology multinational group based on optical technology and after more than 100 years of accumulation, among which digestive endoscopy equipment occupies more than 70% of the global market. The company's endoscopy business and ** instrument business together form the Olympus medical business segment, which accounts for about 80% of the group's overall sales.
It is worth mentioning that China is the world's second largest medical device market, and Olympus is also constantly deepening its layout. In April this year, Olympus China Medical Device Production and R&D Base was established in Suzhou, which became the first time that Olympus set up a production and R&D base for medical device products in China, and it was also the first time that core products were produced outside of Japan.
So, in the process of continuously deepening the business layout and promoting the high-end development of product technology, can Olympus properly solve the recall incident and make every effort to develop the high-end medical device market?The home of equipment will continue to pay attention.