Device product
da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.
Z-2131-2020
Product summary
- Event
- Event 85324
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 305 units
- Official record key
device-enforcement:Z-2131-2020
Official wording
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.
Code information: Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Distribution pattern: Distribution US nationwide and South Korea.
Derived failure modes
-
Unknown
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.