Olympus Medical Systems Corporation

During an inspection of your firm located in Hachioji-shi, Tokyo, Japan, on September 6, 2022, through September 9, 2022, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures gastrointestinal and surgical endoscopes. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Our inspection revealed that your firm's gastrointestinal and surgical endoscopes are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. We received a response from your firm, dated September 30, 2022, to the Form FDA 483 (FDA 483). We address this response below, in relation to each of the noted violation(s). These violation(s) include, but are not limited to, the following:

1. Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example, the information in complaint (b)(4) (MDR# 8010047-2021-02641), complaint (b)(4) (MDR# 8010047-2021-07387), complaint (b)(4) (MDR# 8010047-2021-11050), and complaint (b)(4) (MDR# 8010047-2021-09059), reasonably suggests that your firm’s Uretero-Reno Fiberscope and Uretero-Reno Videoscope malfunctioned (e.g., device breakage or rupture) while in use. Your firm failed to submit an MDR for each of the referenced complaints within the required 30-calendar day timeframe. As a result of these complaints, your firm conducted recall Z-2518-2018, for the Uretero-reno fiberscope URF-P6, where it was established that such events could result in potential perforation of a patient’s organs. Per 21 CFR 803.3, a malfunction is reportable if the manufacturer takes or would be required to take an action under sections 518 or 519(g) of the Act as a result of the malfunction of the device or other similar devices. As such, each of the referenced complaints represents an MDR-reportable malfunction, as defined in 21 CFR 803.3.

The adequacy of your firm’s response dated September 30, 2022, cannot be determined at this time as the response notes that your firm is continuing to implement its systemic corrective actions, including optimizing the MDR reporting process and staff training. However, the adequacy of your firm’s response cannot be determined because your firm’s actions are presently ongoing. When your firm’s corrective actions are completed, please provide documentation or evidence of the systemic corrective actions, including a copy of your revised MDR procedure and a retrospective review of complaints for reportability.

U.S. federal agencies may take your compliance history into account when considering the award of contracts.

Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to correct the noted violation, as well as an explanation of how your firm plans to prevent the violation, or similar violation, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violation included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm's response(s) and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.

Your firm's response should be sent to CDRHWarningLetterResponses@fda.hhs.gov, or if e-mail cannot be used:

Food and Drug Administration - CDRH/ORP/DRP2 CDRH Regulatory Inspections and Audit Team, WO66-1434 10903 New Hampshire Ave. Silver Spring, MD 20993

If you have any questions about the contents of this letter, please contact: Mark Antonino at Mark.Antonino@fda.hhs.gov

Finally, you should know that this letter is not intended to be an all-inclusive list of the violation at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA.