da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery. — recall Z-2131-2020
U.S. FDA — Device Enforcement · United States · 2019-08-19 · Class II
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Reported risk: 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.
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