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Medical News & Perspectives
February 20, 2008

FDA: Patients at Risk of Complications From Unretrieved Medical Device Fragments

JAMA. 2008;299(7):754. doi:10.1001/jama.299.7.754

Clinicians should take special precautions to prevent fragments of medical devices from breaking during procedures and being left in patients, potentially causing serious adverse events, the Food and Drug Administration (FDA) warned in an advisory aimed at reducing such complications (http://www.fda.gov/cdrh/safety/011508-udf.html).

When a medical device breaks during a procedure, fragments may be left in the patient either because the physician is unaware of the break or because attempts to retrieve the fragments have failed. Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction, and death.