da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 305 da Vinci SP Camera units (Model Number 430060-33) distributed nationwide in the US and South Korea. Some cameras were found to have residual soil stuck to the camera tip after reprocessing, which could reduce image quality and potentially require surgeons to switch to a backup camera or change the surgical approach. If residual soil contacts a patient during surgery, it could cause sensitization that would complicate future blood therapy or tissue typing; additionally, if a small piece of inert epoxy is retained, it could lead to scar tissue formation.
The recall notice does not specify what an affected consumer should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Distribution US nationwide and South Korea. Quantity: 305 units Lot/code info: Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.