ConMed Electrosurgery – FDA Warning Letter, Sep 20, 2013

The FDA issued a Warning Letter to ConMed Corporation following an inspection of its ConMed Electrosurgery facility in Centennial, CO, from August 12 to September 20, 2013. The inspection revealed that medical devices, including the Altrus Tissue Fusion System, Hyfrecator 2000, and BiCap Hemostasis Probe, were adulterated as their manufacture, packing, storage, or installation did not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Design Change Procedures (21 CFR 820.30(i)):** Failure to adequately evaluate design changes for Altrus Tissue Fusion System handpieces and controller software, with deficiencies in verification/validation activities, engineering studies, and documentation. The firm's responses were deemed inadequate, with concerns about post-inspection justification of changes. 2. **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)):** Failure to initiate CAPA despite 18 complaints of burns/overheating for the Altrus system, including patient injuries. The firm's focus solely on patient injury for CAPA initiation and reliance on labeling as risk mitigation were inadequate. 3. **Environmental Control Procedures (21 CFR 820.70(c)):** Failure to address product disposition when environmental particulate action