Home Page Lawsuits Filed Lawsuit: Endoscope Lawsuits
By Heidi Turner
Lawsuits have been filed against the makers of some endoscopes—used in endoscopic procedures—alleging the design of the devices is so complex that the endoscopes cannot be properly cleaned, putting patients at risk of developing a superbug. Some studies have found that not all endoscopes are being properly cleaned and the US Food and Drug Administration (FDA) has issued a warning concerning adequate sterilization of endoscopes and endoscopic devices after multiple deaths were linked to endoscopes.
An endoscope is a thin tube with a camera that sends images to a nearby screen attached to one end. It is inserted into the patient's body and used to diagnose or help treat a health issue. In some cases, additional tools are inserted into the body through the endoscope to assist with a procedure. Such tools might include flexible forceps, biopsy forceps, cytology brush, or suture removal forceps.
Endoscopes can be used for a variety of health problems, including those affecting the airways, the joints, the urinary tract and the abdomen. Among endoscope procedures:
Of concern is the growing intricacy of endoscopes, which has led to issues with proper reprocessing—or cleaning—of the endoscopes. Improper cleaning can result in bacteria growing on the endoscope, putting anyone who comes into contact with it at risk of developing a severe infection from a superbug. Such infections can, in some cases, result in death. Lawsuits have been filed against device makers, alleging the device designs prevent proper sterilization from occurring, putting patients at risk of serious health problems.
Health problems arise when an endoscope picks up carbapenem-resistant enterobacteriaceae (CRE) from one patient and spreads it to other patients because it is not properly sterilized.
In February 2015, the US Food and Drug Administration (FDA) issued a warning about improper cleaning of endoscopes and specifically duodenoscopes, which are threaded through the patient's mouth into the throat, stomach and top of the small intestine. According to the FDA, the duodenoscopes have an "elevator" mechanism that allows the doctor to change the angle of the duodenoscope, but that elevator might prevent adequate sterilization of the device. The FDA warned that meticulously cleaning the devices prior to disinfection should reduce the risk of transmitting and infection, "but may not entirely eliminate it."
FDA Endoscope Sterilization Warning
At the time the FDA noted that between January 2013 and December 2014, it had received 75 reports involving around 135 patients who may have become ill due to an improperly sterilized duodenoscope. Among the infectious agents that can be transmitted on an improperly cleaned endoscope are carbapenem-resistant enterobacteriaceae, also known as CRE.
According to reports, 11 patients died after 35 had developed infections linked to endoscope contamination at Virginia Mason Medical Center. Meanwhile, between October 2014 and January 2015, up to 200 patients at UCLA Medical Center might have been exposed to a superbug linked to two deaths and seven infections. Reports indicate that up to 40 percent of patients who develop CRE die from it.
Studies have been conducted concerning the possibility of developing a superbug due to improperly cleaned endoscope devices. One such study was published in BMJ (British Medical Journal). Authors of the study cited a 2013 study, which found that approximately 15 percent of endoscopes in US hospitals did not achieve an accepted standard of cleanliness after liquid reprocessing. Of the devices examined, duodenoscopes had a 30 percent contamination rate while colonoscopes had only a 3 percent contamination rate.
Endoscope Superbug Studies
"The endoscopy itself is not dangerous, but the current cleaning process used between procedures leaves patients susceptible to infection and troubles many healthcare practitioners," the authors wrote.
Lawsuits have been filed against the makers of various endoscopes by patients who became ill following an endoscopic procedure and family members whose loved ones died after contracting a superbug.
Lawsuits have reportedly been filed against Olympus Corporation, maker or the endoscope linked to the UCLA CRE outbreak. The lawsuit was filed by an 18-year-old patient who was allegedly infected by use of the endoscope. In at least one case, a medical center has joined a lawsuit against an endoscope maker, alleging that even when the devices are cleaned according to manufacturer guidelines, patients are at risk of infection. In that case, UCLA joined a lawsuit against Olympus Corp., following an outbreak of drug-resistant bacteria.
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ENDOSCOPE INFECTION LAWSUITS
ENDOSCOPE INFECTION LEGAL ARTICLES AND INTERVIEWS
Olympus Tagged with Partial Liability in Endoscope Lawsuit
Seattle, WA: One of the world’s leading manufacturers of endoscopes, and a target of a wrongful death trial in an endoscope lawsuit, escaped liability for a patient’s fatal infection but was nonetheless compelled to pay almost $6.6 million to the hospital involved for failing to adequately instruct hospital staff [READ MORE]
Scoping the Landscape of Endoscope Infection
Pittsburgh, PA: There is little doubt that endoscopes, duodenoscopes and other intricate scopes designed for ‘internal diagnostics’ are a godsend for patients and used hundreds of times a day, says Dr. Raymond Pontzer of Pittsburgh-based UPMC. “The benefit far outweighs the risks,” the director of infection prevention for the nonprofit said in comments published in the Pittsburgh Post-Gazette (07/04/17). However, the risks cannot be discounted, as many an endoscope infection lawsuit has shown [READ MORE]
ED-530XT Duodenoscopes Recalled
Santa Clara, CA: An urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria [READ MORE]
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I had a colonoscopy in 2013, months later developed pain on right side, pain in my joints, went to rheumatoidologist r/o all types of arthritis etc. then I developed severe diarrhea, occasionally vomiting and dehydration, had to go to emergency room three times in one year for fluids, due to my liver transplant I can not get dehydrated as I could be in serious danger of loosing my organ.
after a 15 months suffering with this problem they did another colonoscopy and endoscopy and I was told I have Whipples Disease. Is it possible that I could have contracted this disease from the first set of colonoscopy and endoscopies? I had two different doctors but the procedures were done at the same location. I am now on my third antibiotic that is not working. The first one worked but my creatine level was continuously rising and they were afraid I would ruin my kidney. The second antibiotic caused me severe nausea, this Penicillin is not doing the trick, I still have pain and the diarrhea came back. I am to be on antibiotics for a year to kill this bacterial infection. Thank you for any information that you can share with me on this .
I had too have a endoscopy&colonoscopy...done in "2015"....sample of tissue was taken from colon&stomach...all came back normal....after biopsy was done....but,experienced off&on infections and was put on antibiotics..afterwards----Same thing recently,I went for same tests.. endoscopy&colonoscopy--Due too stomach issues:pain in lower abdomen,bowel issues,constipation,anemia,dysphagia..trouble swallowing...and,was told a sigmoidoscopy was done w/removal of polyp on colon wall....small tissue taken from my stomach...was sent off for biopsy...later it all came back (normal-negative)I was told by doctor.. but,I truly suffered after procedure had been done and I went home....stomach pain&soreness was unbearable,whinded up with stomachbug/infection..had shortness of breath,heart palpatations,had been put on prednisone (5days plus,antibiotic Arithamycine...also,5days...after procedure....was very sick that I did not think I was gonna make it..plus,my regular doctor telling me.. you don't get well from the steriods&antibiotic...You Will be hospitalized if,no better in a week....well,It seem like I was better after that on the infection....but,still suffering.. everyday with my throat&stomach....and my bowels aren't right.. still can't use the bathroom much...due too constipation...slight amt...of blood...also,after procedure day after procedure... from my rectum area&throat...only slight amt. if blood&it stopped....now facing another procedure...pill capsule test...too be done on me on 11/08/16....doctor still concerned with my lower abdomen....reason he needs this test too swallow capsule pill w/camera too take pictures of all my stomach area too find out anything else of might be causing my problems I been having....plus,when I do use bathroom...sometimes stools are dark...watery....like diarrhia...oR/ very little stool coming out...at times,stomach cramps,pain....etc..
In June 2008 I had a laproscopic hysterectomy . I had incision
Sites on my abdominal area also. These sites became infected
And I was very sick for 2 years. I had 4 debreadments
Within 1 1/2 years. Could this of been from an endoscope?
I have a piece of infected string the surgeon pulled out of
One of the incision sites that tunneled 4".
The last one I had to have a wound nurse 7 days a week
At my home until I healed from the inside out. I was never
So sick in my life!
I had no history of heart problems until I recently had an endoscopy with biopsies of my stomach and small intestine. The reason for the procedure was to check on my celiac which was diagnosed about 7 years ago. After the procedure (within1-2 days) I reported heaviness on my chest and difficulty breathing. The dr. Ignored these complaints. I ended up in the ER with pulmonary edema and congestive heart failure. I was told that the heart problems were probably due to an infection in my heart muscle. I believe the infection in my heart muscle is directly related to th endoscopic procedure. I now have a pacemaker/defibrillator and my ejection fraction is 30 %. Do you think this is grounds for a lawsuit?
I received an endoscopy in 2013 at UCLA for problems that I was having with my esophagus. Subsequently, I was diagnosed with a swollen esophagus. My question is am I still at risk for any side effects, infection,or injury from the use of the endoscope. I am experiencing similary symptoms as to when I had to have the procedure in 2013, however, I am skeptical of having another endoscopy performed.
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