# FDA EIR - Ethicon Endo-Surgery Inc - June 11, 2014

Source: https://www.keypedia.com/records/eir/ethicon-endo-surgery-inc/5410b963-6ff4-4a6c-9c66-82627aea8e1c

> FDA EIR for Ethicon Endo-Surgery Inc on June 11, 2014. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: EIR
- Company Name: Ethicon Endo-Surgery Inc
- Inspection Date: 2014-06-11
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Ethicon Endo-Surgery Inc. at its Cincinnati, Ohio facility was conducted from June 2 to June 11, 2014. The inspection focused on the company's manufacturing of Class I and Class II medical devices, specifically computer-assisted personalized sedation systems and surgical staplers. This visit was prompted by a post-market review for the Sedasys Computer-Assisted Personalized Sedation System and an inquiry into a high volume of Medical Device Reports related to surgical staplers. A comprehensive Quality System Inspection Technique (QSIT) Level 2 assessment also evaluated management controls, design controls, corrective and preventive actions (CAPA), and purchasing controls. The regulatory oversight adhered to established guidelines for medical device manufacturers and premarket approval/postmarket inspections. Significantly, the inspection concluded with "No Action Indicated," meaning no objectionable conditions or regulatory violations were identified. As a result, no FDA Form 483 was issued, and no immediate corrective actions were required from the company.

## Related Officers

- [other](https://www.keypedia.com/people/zach-showman/2bb087de-1efa-4dcc-b91b-933778fab70f)
- [issuing_officer](https://www.keypedia.com/people/roy-c-stephens/54fcc669-ab35-479b-a2f7-5c4d746a3144)
- [other](https://www.keypedia.com/people/m-harriger/55717fba-f71a-4c8b-90cb-7f1742e3f069)
- [investigator](https://www.keypedia.com/people/michael-k-larson/6b398c12-db13-4f7f-9995-dfbcf34b0118)
- [investigator](https://www.keypedia.com/people/allison-mcgloin/b2fb61c4-b39c-4291-8589-ebd7afd13ac4)

Company: https://www.keypedia.com/companies/ethicon-endo-surgery-inc/e4b02e0f-a174-49f9-83ed-20b62aa367e0

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22