Urological Endoscope Infection Lawyers
The FDA has sent out a warning to healthcare providers after three deaths and hundreds of serious infections were linked to medical devices called urological endoscopes. The skilled team of personal injury lawyers at McEldrew Young Purtell Merritt are investigating these infections.
Our law firm regularly handles cases involving medical malpractice and defective medical devices, and our previous work investigating CRE superbug infections linked to duodenoscopes has unfortunate parallels with these new cases involving urological endoscopes. If you or a member of your family have been infected following a medical procedure with a urological endoscope, please contact us immediately for a free consultation concerning your legal rights by calling 1-866-690-2848.
Timeline of Issues Linked to Urological Endoscope Infections
From January of 2017 to February of 2021, the FDA received more than 450 reports citing infections linked to urological endoscopes, including reports of post-procedure infections in patients and issues involving the contamination of devices during the clearing and sterilizing process. These reports cited issues with cystoscopes, cystourethroscopes, and ureteroscopes all from either the Olympus Corporation or Karl Storz manufacturers.
Cystoscopes, cystourethroscopes, and ureteroscopes are used by doctors and other health care providers to provide visualization and access during procedures of the urinary tract. This includes diagnostic and therapeutic procedures on the:
Three deaths were also cited in the FDA’s report. These deaths occured in patients who developed a bacterial infection called Pseudomonas Aeruginosa after their procedures. Two deaths were associated with the use of an accessory component that controls water flow to the endoscope, and one involved a cystoscope that did not pass a leak test, indicating it was damaged when used. All three devices were manufactured by Olympus.
Causes of Infections Linked to Urological Endoscopes
The FDA is still investigating the cause of these infections. Reports indicate that the infections could be linked to a device maintenance issue, or health care providers not following the proper procedure for reprocessing and cleaning the device in between patients. Other possibilities include issues with the design of the device itself, or incorrect instructions from the manufacturer regarding reprocessing the units.
The FDA has not currently issued any recalls or additional recommendations involving these devices. They are encouraging health care providers to report any infections or illnesses that are suspected to be linked to urological endoscopes to their MedWatch Voluntary Reporting Form.
Dangers From Urological Endoscopes Similar to Previous Issues With Duodenoscopes
This recent FDA warning involving urological endoscopes suggests that these devices are possibly experiencing a very similar issue that has affected another type of endoscope, known as a duodenoscope. Duodenoscopes have been plagued by issues for years regarding reprocessing and cleaning the devices, issues that have led to reports of serious hospital infection outbreaks involving aggressive “superbugs”, antibiotic-resistant infections that can cause serious injuries or death.
Duodenoscopes are notoriously difficult to clean in between uses, leading to the potential for bacteria to be transferred from patient to patient. Duodenoscopes were the likely culprit behind several CRE “superbug” infections that originated at Jefferson Hospital in Philadelphia in 2013 and 2014. At UCLA’s Ronald Reagan Medical Center, nearly 200 patients were potentially exposed to CRE after undergoing a procedure with a duodenoscope. The duodenoscopes in question were all manufactured by Olympus, the same manufacturer under scrutiny now.
Urological Endoscope Infection Lawsuits
Numerous lawsuits have been, and continue to be filed against manufacturers of duodenoscopes. In this case, the FDA eventually decided to urge hospitals and health care providers to transition to disposable duodenoscopes as they could not find a way to guarantee to properly reprocess the devices.
These new issues with urological endoscopes have caused the FDA to begin reviewing other types of endoscopes as well to see if similar problems exist across all endoscopic devices. The lawyers at McEldrew Young Purtell Merritt are keeping a close watch on this case as there may be a similar influx of lawsuits against the manufacturers of urological endoscopes as well. If you or someone you know was diagnosed with an infection after a procedure involving a urological endoscope, you should contact our team at 1-866-690-2848 or fill out our form here for a free case evaluation.