FDA EIR - ConMed Corporation - September 20, 2013

The FDA conducted a comprehensive inspection of ConMed Electrosurgery in Centennial, CO, from August 12 to September 20, 2013. This Level II QSIT and Electronic Product Radiation Control (EPRC) inspection focused on the firm's compliance with medical device Quality System Regulation (21 CFR Part 820) and radiation-emitting product requirements. ConMed manufactures Class II electrosurgical generators and associated sterile accessories.

The inspection revealed numerous significant deficiencies, many of which were repeat observations from a prior inspection. Quality System violations included inadequate procedures for design changes, corrective and preventive actions, and establishing device history records. The company's risk analysis was incomplete, complaint handling processes were insufficient, and certain inspection and measuring equipment was deemed unsuitable. Additionally, critical manufacturing processes were not adequately validated, and controls for nonconforming products were deficient.

Pertaining to EPRC, ConMed failed to submit mandatory abbreviated reports before product introduction and lacked essential records and procedures for accidental radiation occurrences, defect notifications, and product remedies. This non-compliance, previously identified, remained unaddressed. Furthermore, design modifications to the Altrus Tissue Fusion System, which increased activation limits, were identified as potentially requiring a new 510(k) submission, rather than merely an internal documentation update.

At the inspection's conclusion, management was issued a 12-item FDA Form 483, to which they largely committed to correcting, except for one observation kept "under consideration." A written response was requested within 15 working days, and the firm was advised of potential enforcement actions for non-compliance.