Olympus GF (endoscopes)

2023: Olympic caught falsifying documents in production

On March 15, 2023, the US Food and Drug Administration (FDA) sent Olympus another warning letter regarding falsified endoscopes and accessories for them.

The document says that the department carried out an audit of the Olympus Medical Systems division in Tokyo from November 7 to 10, 2022. It was found that the company, among other things, supplies distal caps for duodenoscopes and disposable accessories for bronchoscopes. At the same time, the methods used in their production, packaging, storage or installation, as stated, do not meet certain requirements in terms of product quality. In particular, problems with the sterility of products were identified.

Olympus GF Series Endoscope

The FDA notes that since November 2020, Olympus Medical Systems has received about 160 complaints that reported a falling distal end cap. It was found that the number of calls on this problem exceeds the estimated indicator, but the manufacturer did not take "corrective and preventive measures."

In general, as stated by the FDA, the responses received from Olympus on the identified problems are "inadequate." Thus, the company analyzed complaints and reports on medical devices (MDR) for two years related to all products distributed in the United States. Olympus did this to determine if there were signs suggesting impaired sterility of endoscopes. However, it is not clear whether the company analyzed devices supplied to other markets or imported into the United States by a third party. In addition, the FDA said in a letter, Olympus delayed consideration of a number of complaints, which, in accordance with established norms, must be analyzed within 30 days.^[1]

2021: Finding the problems that led to the death of patients

At the end of March 2021, the US Food and Drug Administration (FDA) announced the study of infections and deaths of patients after using reusable urological endoscopes.

Since 2017, the office has received more than 450 reports of substandard medical endoscopy devices in urology, including three deaths linked to cystoscopes, uretheroscopes and cystourethroscopes used to view and access the urinary tract, the FDA said. The reports describe post-procedural infections, as well as concerns about cleaning and disinfecting the devices.

The FDA reported that Olympus and Karl Storz were the most frequently reported companies, but this does not indicate that the use of products only by these manufacturers poses high risks.

Olympus urological endoscopes found problems that led to infection and death of patients

Olympus presented three reports on the deaths of patients outside the United States who developed infections caused by pseudomonas bacillus after the procedure. Two reports of death were related to the use of an instrument-irrigation adapter MAJ-891 designed to control the flow of water and provide access to the working channel of the endoscope.

Another death of the patient was due to a cystoscope, which reportedly failed a leak test. The lack of tightness indicates that the cystoscope was damaged and could also become a source of infection.

The FDA still said that it is impossible to assert with accuracy whether and to what extent the detected pathogens of infection influenced the death of patients, since concomitant diseases could also be a factor in the onset of death.

The FDA letter to health care providers states:

The FDA emphasizes the importance of complying with the manufacturer's labeling and reprocessing instructions for these devices, including cleaning aids to minimize the risk of infection.[2]

2020: Recall of Olympus GF endoscopes spreading infections

In mid-December 2020, Olympus began recalling reusable ultrasound endoscopes due to the risk of infection of patients. According to regulatory reports, 8,522 Olympus GF series devices sold in the US market will be recalled.

In an urgent safety notice, the company listed 23 models of endoscopes that can trap the previous patient's blood or other foreign materials in the air-water channel. These endoscopes are used in difficult-to-diagnose diseases like pancreatic cancer, according to the company. Olympus asks medical staff to carefully examine each endoscope before processing. If a blockage of the air-water channel is found, Olympus recommends not trying to clean it yourself, but contacting the company for repair.

Olympus recalls thousands of Olympus GF endoscopes spreading infections

Contaminated endoscopes can cause patients to become infected with hospital strains of microorganisms, including deadly superbugs. According to company spokeswoman Jennifer Bannan, Olympus reported all complaints received to regulators, but so far patients have not developed serious injuries, so the FDA has assigned a Class II hazard recall.

The recall affected 10 models distributed in the United States, but only three of them are currently available on the market, Bannan noted. Olympus declined to name the total number of endoscopes that could be affected by the recall, but said they were all made in Japan.

Olympus has deployed specialists to health facilities to help doctors and other clients carry out new stages of screening, Bannan said.

According to her, a "Supplement to the Olympus Ultrasonic Endoscope Operating Manual" was sent to all medical institutions, which details the necessary precautions.^[3]

Notes