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FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
Journal Article > Study
Alemzadeh H, Raman J, Leveson N, Kalbarczyk Z, Iyer RK. PLoS One. 2016;11:e0151470.
Using an automated natural language processing tool, this retrospective study evaluated adverse events related to robotic surgery reported between 2000 and 2013. Device malfunctions contributed to many incidents, thus understanding these technical difficulties will be important for avoiding future harms.
Journal Article > Commentary
Schimpff SC. Surg Innov. 2007;14:127-135.
The author discusses approaches to improving safety in the operating room, such as the use of robotics and simulation.
Cases & Commentaries
- Spotlight Case
- Web M&M
Richard H. White, MD ; July-August 2005
An intern increases a patient's warfarin dosage nightly based on subtherapeutic INR levels drawn each morning; after several days, the patient develops potentially life-threatening bleeding.