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Articles Tagged with defective medical device

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A defective surgical staple used to close tissue in the left atrial appendage of the heart is being recalled by the FDA after reports that patients suffered personal injuries such as tissue tears and bleeding  including a possible tear of the left atrial wall (top left chamber) during use of the device.   The manufacturer of the defective medical device, Maquet Medical Systems, sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter to all affected customers asking them to immediately remove and quarantine the Tiger paw System II from their inventory.

Read the press release from the FDA

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CREPatients and family of patients that have been infected by contaminated duodenoscopes at UCLA Hospital started  to file product liability lawsuits against Olympus, the manufacturer of the medical devices. 18 year old Aaron Young was the first one to file his lawsuit. The high school student is still hospitalized and receiving treatment for  carbapenem-resistant Enterobacteriaceae (CRE), a bacteria highly resistant to antibiotics that can kill up to 50% of patients infected. The family  of Antonia Cerda who died in the same hospital after contracting the “superbug” also filed a lawsuit against Olympus for wrongful death, alleged negligence and fraud. Antnonia Cerda was 48 year old and the mother of 4 children.  Both lawsuits have not yet named UCLA as the hospital said the cleaning protocol provided by Olympus was applied.

Today CNN announced that the duodenoscopes used in the procedures that spread the superbug were indeed not approved by the FDA. Olympus started to sell the TJF-Q180V duodenoscope in 2010 without  asking for clearance and the FDA did not become aware until the end of 2013 or beginning of 2014.  Olympus said it didn’t think it needed the FDA’s permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending. Read more on the CNN website

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AED.jpgWhen a person is injured or dies because of an automated external defibrillator failure, it is often the result of a defective design or a manufacturing flaw such as the inadequate quality control of outsourced components. Automated External Defibrillators (AEDs) are usually stored in public places and ready for use if someone suddenly suffers from a life threatening cardiac arrhythmia. Unfortunately these medical devices have a history of malfunctions. In the last 10 years the FDA received more than 72,000 medical reports associated with defective AEDs. During the same period of time, 111 recalls were conducted affecting more than two million defective products.

Therefore the FDA decided to take additional steps to improve the quality of these products. The agency issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these products in the past.

Read the FDA press release here

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defective%20stent.jpg The defective stents may cause serious personal injury such as complications of bleeding, loss of limb, heart attack (myocardial infarction), stroke, vascular surgery, and/or death if they fail to deploy properly.

The LifeStent Solo Vascular Stent manufactured by Bard Peripheral Vascular is an implantable self-expanding stent and delivery system used to improve the inner open space of a blood vessel in patients who have lesions caused by abnormal narrowing of the affected blood vessel.

Defective products were manufactured and distributed from November 2011 to June 13, 2012 , the defective implants code information can be found on the FDA website