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# Multiple QS Violations Found at Helica Instruments
- URL: https://www.fdaweb.com/multiple-qs-violations-found-at-helica-instruments/
- Published: 2016-08-16T12:00:00.000Z
- Updated: 2026-09-14T21:24:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136518

An 11/9/15-11/11/15 FDA inspection at Helica Instruments, Edinburgh, United Kingdom, found multiple Quality System Regulation violations in the firm’s production of an electrosurgical cutting and coagulation device and accessories, including the Helica Thermal Coagulator. A just-released 5/13 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515393.htm?ref=fdaweb.com) says that violations noted on an FDA-483 included: 

- failing to establish and maintain adequate procedures to control product that does not conform to specified requirements;
- failing to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish and maintain procedures for identifying, documenting, validating or, where appropriate, verifying, reviewing, and approving design changes before their implementation;
- failing to establish and maintain procedures to ensure that the device design is correctly translated into product specifications;
- failing to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions;
- failing to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements;
- failing to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development;
- failing to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and addresses the device’s intended use, including the needs of the user and patient;
- failing to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
- failing to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failing to establish and maintain adequate procedures for implementing corrective and preventive action; and
- failing to develop, maintain, and implement written Medical Device Reporting procedures.

The firm’s responses were inadequate or their adequacy could not be determined. The letter also says that the firm does not have an approved PMA or IDE for its Helica Thermal Coagulator and never notified FDA of its intent to introduce the device into commercial distribution. According to FDA, the device received a 510(k) clearance but the firm’s promotion of it indicates a major change or modification to its intended use, for which it lacks clearance or approval. Helica was told to immediately stop activities that result in the misbranding or adulteration of the thermal coagulator, such as its commercial distribution for the unapproved use.

The company was told to take specific steps to correct the violations and to respond with a list of steps taken, documentation of each step, and a timetable for completion.