Infection After Gastroscopy or Upper Endoscopy Lawsuit — Your Legal Rights Against Olympus

What Is the Olympus Scope Lawsuit?

Olympus Corporation — which supplies approximately 70–80% of all endoscopes used in U.S. hospitals — is the subject of pending product liability litigation arising from contamination failures across its flexible endoscope line, including gastroscopes. In December 2018, Olympus Medical Systems Corporation pleaded guilty to three counts of distributing misbranded medical devices and paid $85 million in criminal penalties, admitting it failed to file FDA-required adverse-event reports (Source: DOJ press release, December 10, 2018; Case No. 2:18-cr-00727-SRC, U.S. District Court, D.N.J.).

In October 2025, Olympus issued an Urgent Field Safety Notice for current-generation TJF-series duodenoscopes, admitting that prior reprocessing protocols were insufficient and that hospitals were now required to use 10X magnification tools to properly inspect the scopes — tools they had never previously been told were necessary. The notice confirmed 2 deaths and 5 serious injuries linked to current-generation scopes (Source: Olympus Urgent Field Safety Notice, October 14–17, 2025).

The FDA’s December 2024 Class I Recall of the MAJ-891 Forceps/Irrigation Plug covered 30,140 units distributed in the U.S., with 120+ reported injuries and 1 confirmed death (Source: FDA Recall Z-0905-2025). Stat 10 from the Key Statistics Pull List: Olympus pleaded guilty in December 2018 to three counts of distributing misbranded medical devices and paid $85 million in penalties — admitting it failed to file FDA-required adverse-event reports (Source: DOJ press release).

What Did Olympus Know About Upper Endoscope Contamination?

The 8-year a Dutch tertiary-care hospital retrospective study found that by 2022, 94.7% of patient-ready endoscopes showed measurable bacterial contamination of any type (AM20 contamination — any-organism, not patient-origin bacteria specifically). The patient-origin bacteria (MGO) contamination rate ranged from 14.3% to 47.5% annually. All manufacturer-recommended interventions — disposable endcap designs, new automated reprocessing machines, and staff audits — failed to produce a meaningful reduction in contamination rates over the entire 8-year study period (Source: van der Ploeg et al., Gut, March 2024, PMID 38182137).

The biopsy and suction channels used in gastroscopy were specifically confirmed as the most frequently contaminated components. The October 2025 Urgent Field Safety Notice applied to TJF-series duodenoscopes. However, the underlying contamination mechanism — biological material surviving reprocessing in scope channels — applies to all Olympus flexible endoscopes including gastroscopes. The legal argument in this litigation is that Olympus — not the hospital — was responsible for providing safe cleaning instructions.

Hospitals reported following the reprocessing instructions provided by Olympus at the relevant time. Whether those instructions were adequate, and whether they were in fact followed in every case, are contested issues that have been examined in litigation and in 2016 Senate HELP Committee findings.