An endoscope cleaning device lawsuit is expected following a recall involving Custom Ultrasonics endoscope cleaning equipment that may be linked to serious infection and injury. The Automated Endoscope Reprocessors (AERs) are used to sterilize endoscopes, but after continued violations the U.S. Food and Drug Administration (FDA) is forcing the device maker to recall the machines, defective medical device attorneys note.
If you or a loved one suffered an injury and you suspect that an endoscope cleaning device was the cause, contact Attorney Group for more information about your options. We can answer your questions in a free, confidential, no-obligation consultation, and if you wish to pursue a claim, we can connect you with an affiliated medical device recall lawyer who can assist you through the legal process.
Endoscope Cleaning Device: Lawsuit Expected Following Recall
AERs are free-standing units for disinfecting flexible endoscopes and accessories in hospitals and clinics. The FDA ordered the recall of Custom Ultrasonics’ AERs based on continued violations from its latest inspection in April 2015, as well as the machines’ use in healthcare centers reporting the transmission of serious bacterial infections. According to techtimes .com, 21 complaints relating to Custom Ultrasonics had been received by the FDA since August 2015.
The AER recall includes units:
- System 83 Plus
- System 83 Plus 2
- System 83 Plus 9
The FDA said in a statement that:
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations…and that the identified violations could result in an increased risk of infection transmission.”
The recall is the most recent development in a story that dates to early 2007, when the company entered into a consent decree that prevented it from manufacturing, packing, labeling and distributing until it brought the methods and controls used to manufacture the devices into compliance with FDA standards and requirements. Later that year, the ban was lifted, but it was reimposed in 2012 after the FDA determined that the company was in violation of the consent decree and other regulations. The FDA documented additional violations in 2013 and continued to enforce the ban.
In April 2015, at the company’s request, the FDA said that it would consider letting the company resume operations. But based on a facility inspection and information provided by the company, Custom Ultrasonics is still out of compliance with the consent decree and other regulations, the agency noted.
Injured Patients May Be Entitled to Compensation
Device makers have a duty to design and produce safe products, and to warn of possible risks associated with their products. Failure to fulfill that duty can result in injuries to patients, and the device maker being held liable for those injuries.
Patients who are injured by defective medical devices may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Medical expenses
- Lost wages
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a loved one dies from complications with a defective medical device, his or her family members may be able to pursue claims for wrongful death damages, which include:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Loss of financial support
Affected patients are encouraged to seek the advice of a defective medical device attorney to discuss their legal rights and options for compensation.
If you have been injured by a defective medical device, contact Attorney Group for more information.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.