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duodenoscopes 37 articles

Olympus settles with two widows over faulty endoscopes

Olympus Corp. is feeling the burn for manufacturing and selling specialized endoscopes without warning that they could transmit bacteria from patient-to-patient, leading to life-threatening superbug infections. Last week, the U.S. Department of Justice (DOJ) ordered the Tokyo-based medical-scope maker to pay $80 million in fines and $5 million in criminal forfeiture over its defectively designed duodenoscopes. The company’s former executive, Hisao Yabe, also pleaded guilty for distributing the instruments and not filing reports with the U.S. Food and Drug Administration (FDA) about infections related to Olympus’ duodenoscopes. On the heels of that announcement, Olympus also agreed to pay an undisclosed ... Read More

Olympus pleads guilty for not disclosing infection risks with duodenoscopes

Olympus Corp., was hit with $85 million in fines and forfeiture by the U.S. Department of Justice (DOJ) for distributing specialized endoscopes in the United States without disclosing that the device could spread infections in patients. Both Olympus and the Japanese medical technology’s former top regulatory official, Hisao Yabe, pled guilty to the charges in separate suits in New Jersey federal court. The instruments, called duodenoscopes, are threaded down the throats of patients to treat or diagnose problems with the bile ducts and pancreas. They had been linked to a number of infections in Europe in 2012 and 2013. By ... Read More

Higher-than-expected rate of contamination with specialized endoscopes

Specialized endoscopes used during medical procedures to diagnose problems and perform therapies on bile ducts or the pancreas have a higher-than-expected rate of contamination even after cleaning and disinfecting, the Food and Drug Administration (FDA) cautioned. The agency also reminded health care professionals of the importance of manually cleaning the medical instruments prior to disinfecting or sterilizing, and of properly servicing the devices. The instruments, known as duodenoscopes, are flexible, lighted tubes that are threaded through the mouth, down the throat and stomach to the top of the small intestines. They are complex by design with many small, working parts. ... Read More

FDA issues warnings to three duodenoscope makers

Three medical device manufacturers were warned by the Food and Drug Administration (FDA) for failing to conduct studies on their specialized endoscopes, called duodenoscopes, to determine if their cleaning and disinfecting guidelines were adequate enough to prevent disease-causing bacteria from spreading from patient to patient. Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestines, called the duodenum. They are used during procedures to diagnose and treat problems in the pancreas and bile ducts. Duodenoscopes are used in about a half million procedures in the U.S. each year. The ... Read More

Pentax recalls duodenoscopes to reduce the risk of infection

Pentax is recalling all its ED-3490TK duodenoscopes, a type of specialized endoscope for diagnosing and treating problems in the pancreas and bile ducts, to replace parts and update the Operation Manual. The design changes are intended to reduce the risk of bacteria passing from patient to patient, which could lead to life-threatening infections. Pentax issued an Urgent Medical Device Correction and Removal notification to its customers informing them that it would be replacing the forceps elevator mechanism, O-ring seal and distal end cap of the ED-3490TK duodenoscope to reduce the potential for leakage of patient fluids into the closed elevator ... Read More

First duodenoscope trial begins

A lawsuit filed by the widow of a Washington state man against the manufacturers of a specialized endoscope linked to the spread of deadly superbug infections is the first in the U.S. to go to trial. Theresa Bigler’s lawsuit alleges that Olympus Corp.’s duodenoscope caused the infection that led to her husband’s death in August 2013, and that the medical device manufacturers’ executives failed to warn doctors or patients of this risk. Duodenoscopes are specialized medical devices with flexible, lighted tubes that are fed down a patient’s esophagus to diagnose and treat certain gastrointestinal conditions. The devices have been linked ... Read More

Fuji film pulls four duodenoscopes from market due to health risk

Fujifilm Medical Systems is removing four older models of specialized endoscopes known as duodenoscopes in the United States due to known safety risks to patients, according to a Food and Drug Administration Safety Alert. The company announced that it plans to remove models ED-250XL5, ED-250XT5, ED-450XL5, and ED-450XT5 duodenoscopes in the U.S., which are only currently in use in a “limited number” of medical centers. Fujifilm said the move was purely a “business decision” and that it would be providing its U.S. customers with its more recent model of duodenoscope, the ED-530XT. Duodenoscopes are devices that are threaded down the ... Read More

Olympus Execs Mum During Depositions Over duodenoscope Contamination

Olympus Corp. executives refused to answer questions about their e-mail correspondence discussing how to handle the deadly U.S. superbug outbreaks linked to Olympus duodenoscopes during two days of recent depositions. Lawyers for plaintiffs suing Olympus for wrongful death, negligence, or fraud interviewed three top-ranking Olympus officials in Tokyo on Nov. 30 and Dec. 1, seeking answers as to why the company warned European customers about the risks of infection posed by their medical camera devices but failed to alert U.S. customers. At least 35 patients have died in U.S. hospitals after undergoing procedures performed with an Olympus duodenoscope – a ... Read More

Researchers sound the alarm on top health tech hazards to watch out for in 2017

Infusion errors with large-volume infusion pumps, infection risks with reusable instruments and heater-cooler devices, and opioid monitoring challenges are among the top health technology hazards that hospitals and clinicians should focus on in 2017, according to the ECRI institute, a nonprofit research organization. ECRI’s Health Devices Group compiles the list of top health tech hazards annually to identify potential sources of danger that warrant the greatest amount of attention in the coming year. “Technology safety can often be overlooked when hospital leaders are dealing with so many other issues,” David T. Jamison, executive director of the Health Devices Group at ... Read More

Public invited to report medical device makers who violate the law

The Food and Drug Administration has launched a new portal on its website for consumers to report medical device manufacturers or medical device marketers who may be in violation of the law. The website, called Reporting Allegations of Regulatory Misconduct, invites anyone to report any suspected suspicious activities by makers or marketers of medical devices. Examples of allegations include promoting or advertising a device that has not been cleared or approved by the FDA; failing to report safety concerns or adverse events to the FDA; manufacturing devices that don’t meet design requirements; or hiding information from the FDA such falsifying ... Read More