Intuitive Surgical, Inc. recalls da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Recall date

August 19, 2019

Source

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

Recall number

Z-2131-2020

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Distribution US nationwide and South Korea.

Why it was recalled

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

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

What was recalled

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.