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

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 "