Recall Z-2131-2020— Intuitive Surgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2019-08-19. It names one FDA 510(k) clearance: K173906. Product: da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.. Reason: 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..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-08-19
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.