# FDA 483 - Richard Wolf Medical Instruments Corp. - March 18, 2020

Source: https://www.keypedia.com/records/483/richard-wolf-medical-instruments-corp/029b2b66-9035-456e-8ae2-49920e5337b7

> FDA 483 for Richard Wolf Medical Instruments Corp. on March 18, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard Wolf Medical Instruments Corp.
- Inspection Date: 2020-03-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: Richard Wolf Medical Instruments Corp. in Vernon Hills, IL, received a Form FDA 483 for failing to submit a Medical Device Report (MDR) within the required 30-day timeframe. The firm became aware of a malfunctioning insufflator and TEM pump that delayed a surgery in August 2018 but did not report it to the FDA until March 2019. This indicates a significant delay in reporting a device malfunction that could contribute to serious injury if it were to recur.

## Related Documents

- [WARNING_LETTER - 2013-05-08](https://www.keypedia.com/records/warning_letter/richard-wolf-medical-instruments-corp/eb9de329-a673-4c02-9a2c-914e750544ed)
- [483 - 2018-07-17](https://www.keypedia.com/records/483/richard-wolf-medical-instruments-corp/2cf4bf45-6623-43c2-83ac-f3db4eb2f6d2)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/richard-wolf-medical-instruments-corp/35a87eec-34b1-4a3a-afc3-17b2c19ec98d

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669