PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 3, 2020 Initiated: August 19, 2019 #Z-2131-2020

Product Description

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

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
305 units
Distribution
Distribution US nationwide and South Korea.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.. Recalled by Intuitive Surgical, Inc.. Units affected: 305 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2131-2020.