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Research Letter
April 2016

Morbidity and Mortality Associated With Robotic Head and Neck SurgeryAn Inquiry of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Author Affiliations
  • 1Division of Head and Neck Surgery, Department of Otolaryngology, Stanford University, Palo Alto, California
JAMA Otolaryngol Head Neck Surg. 2016;142(4):405-406. doi:10.1001/jamaoto.2015.3673

Transoral robotic surgery (TORS) using the da Vinci Surgical System (Intuitive Surgical) was first approved for use in otolaryngology by the Food and Drug Administration (FDA) in 2009. With increased adoption of this technology, the head and neck surgical community should continue to evaluate its safety and efficacy.

The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a publicly available national database that allows the anonymous reporting of adverse events (AEs). Since December 13, 1984, the FDA has required device manufacturers to report any device malfunctions, serious injuries, or deaths associated with medical device use by means of this database.1 We review reported data in MAUDE and describe the morbidity and mortality associated with the robotic head and neck surgery.

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