FDA WARNING_LETTER - Munroe Regional Medical Centre - September 21, 2009

On September 14, 15, and 21, 2009, an FDA inspection of Munroe Regional Medical Center, Inc. in Ocala, Florida, revealed the facility, a medical device user facility, was not in conformance with Medical Device Reporting (MDR) regulations (21 CFR Part 803). The EsophyX™ devices used at the facility were deemed misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failure to furnish required information.

Violations included: 1. **Failure to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17):** An incident on July 29, 2009, involving a patient suffering a torn esophagus during an EsophyX™ procedure, was determined by Munroe not to be serious or reportable without documented justification. The facility's revised policies lacked provisions for timely identification, communication, and evaluation of reportable events; a standardized review process for reporting criteria; timely transmission of reports; and documentation/recordkeeping of evaluation information. 2. **Failure to maintain complete MDR event files (21 CFR 803.18(b)(1)(i)):** The July 29, 2009, incident report did not document the deliberations and decision-making processes for determining reportability. 3