The increasing technological sophistication of hospital care has led to greater appreciation of the potential safety hazards posed by medical devices. This observational study used the AHRQ Patient Safety Indicators to examine whether the introduction of a new medical device, the da Vinci robot, led to a change in surgical processes or surgeon performance for a specific procedure, radical prostatectomy. The authors found that during initial adoption of the new technique and device, there was an increased risk of unsafe practice compared with the standard method of conducting radical prostatectomy. This finding emphasizes the need to create safety processes and monitoring when novel devices and procedures are introduced, given that voluntary reporting underestimates safety problems related to devices. A recent AHRQ WebM&M perspective discusses the challenges associated with ensuring medical device safety in the complex health care environment.