HARMONIC ACE Curved Shears Instructions for Use recalled over fire hazard

Recall date

January 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Intuitive Surgical, Inc. recalls HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Inten…

Recall number

Z-1117-2015

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russia…

Why it was recalled

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System