FDA-Device2020-06-03Class II
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Intuitive Surgical, Inc.
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.
Sold states
Distribution US nationwide and South Korea.
Affected count
305 units
Manufactured in
1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, United States
Products
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2020Don't want to check this manually?
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