# FDA 483 - Karl Storz Endovision, Inc. - June 14, 2022

Source: https://www.keypedia.com/records/483/karl-storz-endovision-inc/f7c2b3fb-1f4f-49c6-8575-a100157c415c

> FDA 483 for Karl Storz Endovision, Inc. on June 14, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Karl Storz Endovision, Inc.
- Inspection Date: 2022-06-14
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Karl Storz Endovision, Inc. in Charlton, MA, revealed a significant deficiency in their risk analysis procedures. The firm failed to conduct adequate and complete risk analyses for flexible endoscopes utilizing the T-Luer feature, despite this feature being identified as a factor in device-associated infections and subject to an ongoing recall. This indicates a serious lapse in design control and product risk management.

## Related Documents

- [WARNING_LETTER - 2014-10-29](https://www.keypedia.com/records/warning_letter/karl-storz-endovision-inc/eacae5de-3786-48e7-975d-7a076004b4bc)
- [EIR - 2021-09-17](https://www.keypedia.com/records/eir/karl-storz-endovision-inc/5eb239d0-52dd-4647-8747-277e4b9a0675)
- [483 - 2021-09-17](https://www.keypedia.com/records/483/karl-storz-endovision-inc/fc985e3d-2928-4ded-949a-59af235858f7)

## Related Officers

- [Angel A Soler-Garcia](https://www.keypedia.com/people/angel-a-soler-garcia/63e4e12a-05a1-4a59-ae29-ecd4c343bb5f)
- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/karl-storz-endovision-inc/ccba1a5b-ab36-46d6-aa92-dbd2fab934b7

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94