Duodenoscope Lawsuit News: FDA Announces Voluntarily Recall of Duodenoscopes After Risk For Bacterial Infection

   

Duodenoscope Lawsuit Filings Maintain Design Flaws In Medical Scopes Cause Transmission Of Deadly Superbug Bacteria During Endoscopic Proceedures.

duodenoscope-infection-lawsuit-duodenoscope-lawsuitsDuodenoscope Infection Lawsuit News: The Endoscopy Division of Fujifilm Medical Systems U.S.A., has voluntarily recalled its ED-530XT model duodenoscopes due to problems with effectively cleaning and disinfecting the devices. The U.S. Food and Drug Administration (FDA) announced the Duodenosscope recall on July 21. Duodenoscopes that are not properly sanitized have the potential to transmit a “superbug” bacteria to patients during endoscopy procedures. Patients infected by Carbapenem-resistant enterobacteriaceae (CRE) are filing duodenoscope lawsuits against the medical device manufacturers alleging design flaws make it difficult to clean the medical devices which creates a risk for transmitting deadly bacteria.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm567793.htm]

“The superbug bacteria is nearly resistant to antibiotics and may cause serious and fatal injuries to patients who contract a superbug infection,” says Dr. François Blaudeau, founder of Southern Med Law. “We are hoping the recall will stop more patients from contracting the potentially dangerous bacterial infections from the device”.

Southern Med Law is investigating potential duodenoscope infection lawsuit claims on behalf of men and women–or their surviving loved ones–who contracted a superbug infection following an endoscopy procedure. To arrange for a free, no obligation legal consultation, please call Southern Med Law today, at (205) 547-5525. More information about this issue can be obtained by visiting www.southernmedlaw.com.

According to the FDA’s Safety Communication, Fujifilm will replace the ED-530XT forceps elevator mechanism including the O-ring seal, and the distal end cap, and issue new operation manuals. On July 21, Fujifilm sent an Urgent Medical Device Correction and Removal notification advising health care professionals to continue using the device until contacted by the company for replacement parts as early as October. Also on July 21, the FDA cleared the updated design and labeling for the ED-530XT. The FDA said it worked with Fujifilm in 2015 as the company modified and validated manual cleaning and disinfecting instructions for the ED-530XT model.
[accessdata.fda.gov/cdrh_docs/pdf15/K152257.pdf]
[fujifilmusa.com/products/medical/endoscopy/pdf/UrgentFieldCorrectionAndRemoval_ED530XT_072117.pdf]

Fujifilm’s ED-530XT model duodenoscopes allow examiners, such as gastroenterologists, to view a patient’s duodenum and upper digestive tract in order to observe, diagnosis, and treat the esophagus, stomach, and duodenum. In 2015, the FDA sent warning letters to Fujifilm, Olympus and Pentax for inadequately reporting problems with their duodenoscopes and failing to make sure the endoscopy devices could be cleaned properly between uses. According to the FDA, the complex design of duodenoscopes makes it difficult to clean and disinfect even when users properly follow the manufacturers’ instructions. If not properly cleaned and disinfected, dangerous bacteria that gets into cracks and gaps of a scope can be transmitted to patients.
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm537146.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery]

Over the past two years, CRE infection outbreaks stemming from contaminated duodenoscopes have occurred at hospitals and medical centers nationwide. The outbreaks have prompted lawsuit filings in state and federal courts on behalf of patients who contracted a superbug infection. Most duodenoscope contamination lawsuits have been filed against Olympus Corp. The lawsuits claim Olympus Corp. knew that its duodenoscopes had design flaws that made it difficult to properly clean and disinfect. The complaints further accuse Olympus of failing to warn hospitals, doctors and patients that use of contaminated scopes could cause dangerous infections or death. Kaiser Health News reported at least 35 patients in hospitals have died since 2013 after developing infections stemming from contaminated Olympus duodenoscopes.
[khn.org/news/grilled-about-deadly-superbug-outbreaks-execs-at-scope-maker-olympus-take-fifth/]

About Southern Med Law And Filing A Duodenoscope Lawsuit

Southern Med Law is an experienced law firm with the proven experience to fight large corporation. Led by Dr. François Blaudeau, an attorney and a practicing doctor, the firm continues to provide legal representation to the men and women across the country who have been victims of personal injuries, medical malpractice, dangerous drugs, and defective medical devices. The legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions including those involved in duodenoscope infection lawsuits. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
francois@southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam
www.southenmedlaw.com
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