How Olympus Defied FDA Postmarket Surveillance Orders — And Kept Selling Contaminated Duodenoscopes

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What Is an FDA Postmarket Surveillance Order and Why Did Olympus Receive One?

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360l) authorizes the FDA to order manufacturers of Class II or Class III devices to conduct postmarket surveillance when there is reason to believe the device may present a serious risk to health. Following the February 2015 Safety Communication acknowledging that Olympus duodenoscope cleaning instructions “may be inadequate,” the FDA ordered Olympus to conduct mandatory postmarket surveillance of its duodenoscopes. The surveillance order required Olympus to establish surveillance sites — hospitals actively using duodenoscopes — where real-world contamination rates, infection transmission rates, and patient outcome data would be systematically collected and reported to the FDA.

This was not a suggestion or a recommendation. Section 522 orders are mandatory. Failure to comply constitutes a regulatory violation. The FDA issued the order because it had reason to believe Olympus duodenoscopes presented a serious risk to health — a conclusion supported by the 75 Medical Device Reports (MDRs) covering approximately 135 patients that had already been received at the time of the February 2015 Safety Communication.

The Senate HELP Committee report Preventable Tragedies (January 13, 2016) documented that Olympus had been receiving reports of contamination-linked outbreaks since fall 2012, and had failed to report that information to the FDA through the period covered by the Section 522 order. The surveillance order was the regulatory response to a three-year pattern of non-reporting — and Olympus defied it.

What Did Olympus Do After Receiving the Surveillance Order?

Nothing. More than two years after the Section 522 surveillance order was issued, the FDA sent Warning Letter MARCS-CMS 546986 in March 2018 documenting that Olympus had established zero surveillance sites. Not one hospital. Not one data collection protocol. Not one data point submitted to the FDA. (Source: FDA Warning Letter MARCS-CMS 546986, March 2018.) The timing of the surveillance defiance makes the conduct more serious, not less.

While Olympus was ignoring the mandatory surveillance order, the company was simultaneously under active criminal investigation for failing to report adverse-event information to the FDA — the same FDA that had ordered the surveillance. The Department of Justice criminal investigation that resulted in the December 2018 guilty plea was proceeding during the same period that Olympus was defying the surveillance order.

The criminal reporting-failure period (adverse events omitted from FDA MDRs, 2012–2018) overlaps precisely with the surveillance non-compliance period (order issued 2015, zero sites confirmed March 2018). Olympus pleaded guilty on December 10, 2018, paying $85 million and admitting to 3 counts of distributing misbranded medical devices by failing to report adverse-event information to the FDA during the period when US hospital outbreaks were occurring (Case No. 2:18-cr-00727-SRC, D.N.J.).

Nine months earlier, the FDA had documented that Olympus had also ignored the mandatory order to collect safety data that would have added to that same adverse event record. Two simultaneous regulatory violations — criminal reporting failure and surveillance defiance — during the same period. (Source: DOJ press release, December 10, 2018.)

What Would Postmarket Surveillance Have Shown?

If Olympus had established surveillance sites and collected data as ordered, the FDA would have received systematic contamination rate data beginning in 2015 or 2016. We know what that data would have shown because independent researchers collected it without Olympus’s cooperation. A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5 percent contamination even after enhanced cleaning protocols, with 0.8 percent high-risk organisms.

(Citation: Bomman et al., Clinical Endoscopy, January 2022, PMC8831410.) An 8-year retrospective study found 94.7 percent AM20 contamination by 2022 and confirmed that all manufacturer-recommended interventions — disposable endcaps, new automated reprocessors, staff audits — failed to produce a meaningful reduction in contamination rates. (Citation: van der Ploeg et al., Gut, 2024;73(4):613–621, PMID 38182137.) The October 2025 Urgent Field Safety Notice issued by Olympus subsequently confirmed why all interventions failed: the underlying inspection protocol itself was inadequate and required 10X magnification tools that hospitals had never been told to use.

Real-world surveillance data — the data Olympus refused to collect — would have confirmed these contamination rates years before the academic literature did. Had Olympus complied with the surveillance order and submitted accurate data to the FDA, the regulatory response would have been earlier, more comprehensive, and potentially life-saving. Olympus’s refusal to collect this data was not a passive failure. It was an active choice to prevent adverse event information from reaching the agency during the same period the company was already criminally failing to report that same category of information.

What Is the Legal Significance of Olympus’s Surveillance Non-Compliance?

Surveillance non-compliance has three direct legal consequences for product liability plaintiffs. First: it extends the knowing non-reporting period. The criminal plea established criminal reporting failure through December 2018. The surveillance defiance extended the regulatory obstruction through at least March 2018 — the two periods overlap and reinforce each other. Olympus was not merely slow to act on its safety obligations.

It was actively defying a mandatory safety order while simultaneously being criminally investigated for failing to report the very data the order was designed to generate. Second: it supports a failure-to-warn claim. Olympus’s refusal to collect surveillance data prevented both the FDA and individual hospitals from understanding the true scope of the contamination problem. Had the surveillance data been collected and submitted as required, hospital infection control professionals and FDA regulators would have had systematic, manufacturer-generated data on contamination rates and patient outcomes — data that would have enabled earlier interventions.

Olympus’s failure to generate and submit that data is evidence of a systemic failure to warn. The Virginia Mason outbreak (32 patients, 7 died within 31 days, MDR E. coli recovered from 4 of 8 scopes) and the CRE outbreaks at the Illinois teaching hospital (39 patients, NDM-producing E. coli) and UCLA (17 patients, 2 deaths) were all occurring during the surveillance non-compliance period. (Sources: PMID 26092616; PMID 25291580; PMID 29579235.) Third: it is direct regulatory evidence of the company’s disregard for patient safety throughout the claims period.

A defendant that defies a mandatory safety order — while under criminal investigation for the same conduct the order is designed to prevent — cannot credibly argue it acted in good faith toward patient safety. The surveillance non-compliance, the criminal reporting failure, the 2023 warning letter for failing to investigate the MAJ-2315 distal end cover cracking defect, and the FDA Import Alert 89-04 issued in June 2025 blocking 58 Olympus device models from the United States form a continuous pattern of regulatory resistance spanning more than a decade.

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