PENTAX ED-3490K Duodenoscope May Cause Infection if Not Adequately Cleaned

PENTAX has acknowledged a potential risk of infection associated with the design and manufacturing of the PENTAX ED-3490K duodenoscope, the FDA said today, January 17, 2017.

According to the FDA, PENTAX has stated that silicone applied during manufacturing of ED-3490TK duodenoscopes can, in some instances, crack and gaps may form in the silicone adhesive that may lead to microbial ingress, meaning dangerous bacteria, including E. coli and Klebsiella, can hide in them. Hospitals need to thoroughly clean and sanitize these devices to prevent the spread of disease.

E coli Bacteria
E. coli bacteria under a magnification of 6836x.

If a sick person has a procedure using a PENTAX ED-3490K duodenoscope, bacteria from that person may lodge in the silicone and infect the next patient in which the duodenoscope is inserted. These medical devices are used for endoscopic retrograde cholangiopancreatography (ERCP), a procedure to diagnose and treat problems in the pancreas and bile ducts. Duodenoscopes used for ERCP are sometimes referred to as ERCP endoscopes.

Outbreaks of severe illness involving duodenoscopes made by other manufacturers have resulted in dozens sickened and several deaths.

If you or a family member has contracted a hospital infection after an ERCP procedure, contact attorney Fred Pritzker for a free consultation.

Can I Sue PENTAX for an Infection from an ERCP Procedure Using an ED-3490K Duodenoscope?

Yes, you can sue for an infection from an ERCP procedure using a PENTAX duodenoscope if there is evidence that your illness is associated with the use of that device. A lawsuit could seek compensation for medical expenses, lost income, pain and suffering, loss of companionship and other damages. If your loved one has died, you may have a wrongful death claim.

Your case may involve one or more of the following:

  • Acinetobacter
  • E. coli
  • Enterococcus
  • Enterobacter
  • Klebsiella pneumoniae
  • Methicillin-sensitive Staphylococcus aureus (MSSA) or methicillin-resistant Staphylococcus aureus (MRSA)
  • Pseudomonas aeuroginosa.

These bacteria can cause different types of healthcare-associated infections, including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis.

Outbreaks of infection have involved carbapenem-resistant Enterobacteriaceae (CRE), a family of germs that are difficult to treat because they have high levels of resistance to antibiotics, including carbapenem, a last-resort medication. E. coli and Klebsiella can be CRE infections.

Bad Bug Law Team - Pritzker


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Category: Product Liability
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