FDAAugust 19, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

intuitive surgicalintuitive

UPCs

00886874114384

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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