Category Archives: Duodenoscope

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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FDA Investigation Finds Underreporting of Medical Device Problems

FDA Finds Underreporting of Medical Device Problems

Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify … Continue reading

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Tainted Medical Scopes Allegedly Cause Superbug Infections

Tainted Medical Scopes Allegedly Cause Superbug Infections

The Olympus Corporation, based in Japan, was allegedly aware of superbug outbreaks in three countries as early as 2013 and did not alert American hospitals about possibly deadly infections from contaminated medical scopes known as duodenoscopes. After two-dozen infections were … Continue reading

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FDA Urges Hospitals to Stop Using Custom Ultrasonics Duodenoscope Cleaning Machines

The Food and Drug Administration (FDA) has taken new steps in its efforts to deal with a series of superbug infections linked to the duodenoscope, a device used to examine the intestinal tract to diagnose and treat conditions including gallstones. … Continue reading

Posted in Defective Medical Devices, Duodenoscope, Health Concerns |

Senate Report Critical of Medical Device Makers’ Failure to Report Infections

duodenoscopes

A Senate report released on January 13, 2016 finds that superbug infections linked to poorly cleaned medical devices have been more widespread than previously known. The reports places blame on hospitals, device makers, and the Food and Drug Administration (FDA). … Continue reading

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Investigation Shows Olympus Failed to Alert Authorities to Deadly Bacteria Found on Medical Scopes

bacteria

In spring 2012 at a Dutch hospital, a technician for Olympus, maker of medical scopes, found a brown, grimy film inside parts of the flexible scope that were supposed to be sealed, and a rubber ring designed to keep bacteria … Continue reading

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FDA Orders Custom Ultrasonics to Recall AERs Used to Clean Duodenoscopes

FDA order Recall on AERs Used to Clean Duodenoscopes

The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being … Continue reading

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Olympus Faces Wrongful Death Lawsuit over Contaminated Duodenoscope

Olympus Faces Wrongful Death Lawsuit over Duodenoscope

A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an … Continue reading

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