The US Senate released the details of an investigation relating to medical scopes that are manufactured by Olympus Corp., a national frontrunner when it comes to the production and sales of duodenoscopes. Olympus Corp. has voluntarily recalled 4,400 of its medical scopes due to a large number of infections and deaths that have highlighted the urgent need for product redesign. The Senate’s report documents hundreds of people over the past few years who have experienced antibiotic-resistant infections, as well as some who have even died, and all because of a product feature that limits proper sterilization.
Duodenoscopes are commonly used to drain built-up liquids that have gathered in the bile ducts or pancreas, sometimes caused by gallstones, tumors or other medical conditions. The Food and Drug Administration had been documenting the problems arising from the use of Olympus Corp.’s duodenoscopes and lodged complaints with the company. In response, Olympus Corp. decided to implement a system of annual inspections as well as to construct a new design to allow for full sterilization of the medical scope.
The issue with Olympus Corp.’s duodenoscopes brings light to an even bigger problem at play: there was a major communication breakdown on nearly every front when it came to reporting the damages and injuries that the product was inflicting on patients. Olympus Corp. itself failed to properly report and document the issues associated with its product, and infection outbreaks related to the duodenoscopes were not reported by hospitals on a federal level. It took more than three years to recall the TJF-Q180V model medical scope, which means that for three years people who went to receive medical treatment from professionals were put at risk for antibiotic-resistant infections and even death because of improperly manufactured, faulty medical equipment.
The Senate’s full report on the findings relating to Olympus Corp.’s duodenoscopes can be viewed here. It shows how dangerous product design has been harmful, even fatal, to hundreds of Americans who received medical procedures with Olympus Corp.’s duodenoscopes, and also condemns the ineffective monitoring that took place when it came to recording areas of concern. For now however, the TJF-Q180V model has officially been recalled and Olympus Corp. is working on a redesign that is safe for medical consumers.
Philadelphia Products Liability lawyers at Galfand Berger have successfully represented clients who have been injured by faulty or malfunctioning medical products. If you or any of your loved ones have experienced such a situation, an attorney at Galfand Berger, LLP can help. With offices located in Philadelphia, Reading and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.