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- Device Malfunctions
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Journal Article > Study
Dominguez ED, Rocos B. Cureus. 2019;11:e4877.
This analysis of the National Reporting and Learning Service database (the United Kingdom's voluntary error reporting system) identified numerous cases of patient harm due to malfunctioning surgical equipment, the most common involving unretrieved device fragments (such as broken drill bits). The authors contend that lack of a standardized reporting and tracking system for surgical instrument malfunctioning poses a potential threat to patients. A WebM&M commentary discussed an incident involving life-threatening hemorrhage due to a broken surgical instrument.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.