Getsch+Hiller Medizintechnik GmbH

During an inspection of your firm located in Tuttlingen, Nendingen, Germany on July 18, 2022 through July 21, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Monopolar Laparoscopic Instruments with disposable and reusable instrument tips. 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 function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Florian Herb, QMR dated August 8, 2022 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We received an additional response dated October 27, 2022 which is currently under review. We address the August 8, 2022 response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain design history file (DHF) for each of the products that GH manufactures, as required by 21 CFR 820.30(j).

For example: your firm has not established a Design History File (DHF) for its line of Class II Monopolar Laparoscopic Instruments with reusable instrument tips, exported and intended for the US market.

We reviewed your firm’s response and concluded that it is not adequate. CDRH acknowledges that your firm’s response states the firm corrective actions are planned for revising, Procedure, (b)(4) Development, which will describe a DHF and what a retrospective DHF looks like. While your response indicated the firm has voluntarily blocked the products from shipment to the United States after the July inspection, it is not clear that your risk assessment is adequate, because your response did not address evaluation of the risks for devices already distributed in the US (e.g., Health Hazard Evaluation) or any potential subsequent efforts for correction and removal.

2. Failure to establish and maintain procedures for acceptance of incoming product as required by 21 CFR 820.80(b).

For example: during the inspection on July 20, 2022, of your firm’s CNC Department, the investigator identified multiple raw materials that according to staff had not gone through your firm’s incoming acceptance process, but which had been labeled with your (b)(4) system generated inventory sticker and staged next to approved raw materials also labeled with your (b)(4) inventory sticker. Per your firm’s staff, the (b)(4) inventory sticker identifies approved raw materials, and these raw materials are used in the manufacturing of medical devices by your firm, however they were not properly identified to ensure that only product which has passed the required acceptance activities are distributed or used.

We reviewed your firm’s response and concluded that it is not adequate. CDRH acknowledges that your firm’s response states your firm’s corrective actions include applying missing markings for quarantine stock areas in the company, creating/implementing procedures for product identification and training employees. However, your response does not mention a plan to analyze existing records to determine whether there is a risk that the inappropriately received raw material impacted in-process or finished device specifications and to determine the risk that nonconforming product was released for distribution (including actions to be taken to mitigate such risks).

Our inspection also revealed the Monopolar Laparoscopic Instruments are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device. The Monopolar Laparoscopic Instruments are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with significant changes or modifications that require a premarket notification to FDA under section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3).

Specifically, these devices were cleared under K171523 as “Monopolar Single Use Laparoscopic Instrument.” The 510(k) Summary for K171523 includes, in part, the following Device Description (emphasis added):

The Monopolar Single Use Laparoscopic Instruments of Getsch + Hiller is available in two different designs. It is available as system consisting of two parts and as a system consisting of four parts.

The 2-part system is available with reusable handle assembled with a completely insulated shaft on which only a single use tip has to be fixed by the user. This has a working length of 330 mm.

The 4-part system consists of a reusable handle and a reusable shaft insulated, a connection rod with easy snap lock and a single use tip. The system has to be assembled by the user. The 4-part system is available with a working length of 330 mm and 450 mm.

Different types of single use tips are offered for both systems, Maryland grasping forceps, Endoclinch grasping forceps, Aggressive grasping forceps and Johan grasping forceps. Furthermore, Metzenbaum scissors in different sizes, straight or curved, are available.

However, your firm is manufacturing reusable tip inserts. Your instructions for use describe cleaning and sterilization procedures for these inserts and state, “50 reprocessing cycles can be performed for the inserts and ‘inserts fixed to the shaft.’” The Laparoscopy Catalog notes about “Detachable Instruments” that, “For sterilizing purposes, the instruments may be detached into 2-parts (3 mm instruments) or 3-parts (3,5/5/10 mm instruments) of components. All items are compatible with each other and can be sterilized easily.” These use descriptions go significantly beyond the clearance in K171523 and provide evidence that device components that were cleared for single use are now intended for multiple use following reprocessing. Such a change from single use tips to reusable tips constitutes a change or modification in the device that could significantly affect the safety or effectiveness of the device, for which your firm lacks clearance or approval.

For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

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 address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, 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. Please provide a translation of documentation not in English to facilitate our review. 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.

Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #644680 when replying. If you have any questions about the contents of this letter, please contact: Colin Kejing Chen, Ph.D. at 301-796-6390.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.