# FDA 483 - Virginia Mason Medical Center - April 15, 2016

Source: https://www.keypedia.com/records/483/virginia-mason-medical-center/5c4e627a-74b3-4823-9f72-fc418fc4e91f

> FDA 483 for Virginia Mason Medical Center on April 15, 2016. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Virginia Mason Medical Center
- Inspection Date: 2016-04-15
- Office Name: Seattle District Office
- Summary: This FDA Form 483 documents observations from an inspection, citing deficiencies in Medical Device Reporting (MDR) procedures and record-keeping at the facility.

**Violations and Observations:**

1.  **Incomplete MDR Event Files:** MDR event files lack comprehensive adverse event information, including documentation of reportability determinations.
    *   **Specific Instances:**
        *   39 patients undergoing ERCP procedures were found to harbor multidrug-resistant E. coli, which was also found on duodenoscopes used. No documentation showed review for reportability to the manufacturer.
        *   A patient safety alert regarding a failed patch angioplasty after carotid endarterectomy lacked documentation of review for reportability to the manufacturer.

2.  **Failure to Submit Timely Reports to Manufacturer:** The user facility did not submit FDA Form 3500A or equivalent to the known device manufacturer within 10 working days of becoming aware of information suggesting a device caused or contributed to a serious injury.
    *   **Specific Instance:** An object was surgically removed due to migration and bowel obstruction. While a mandatory report draft was completed, documentation of all required information being submitted to the manufacturer prior to the MedWatch report was absent.

3.  **Refusal to Permit Copying of Records:** An authorized FDA employee was not permitted to copy MDR-required records.
    *   **Specific Instance:** The firm refused to provide a copy of a "

## Related Officers

- [Senior Quality Engineer](https://www.keypedia.com/people/sharon-gundersen/5bc43dc9-a52b-4e19-b8c2-75fd37e8e175)
- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)
- [Christopher M. Jenner](https://www.keypedia.com/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)

Company: https://www.keypedia.com/companies/virginia-mason-medical-center/06bf37b2-f5ff-4047-9481-300835e3e70b

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913