Device product
Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Z-0835-2015
Product summary
- Event
- Event 69845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1532
- Official record key
device-enforcement:Z-0835-2015
Official wording
Reason: The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.
Code information: PN 950156-02
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence.