Device product
SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
Z-1103-2023
Product summary
- Event
- Event 91291
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-1103-2023
Official wording
Reason: A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device
Code information: UDI: 00815686020101 Serial Numbers: 85330200430, 87896220519, 87899220524, 87379210921, 87835220505, 87832220502, 87767220420, 87777220415, 87827220427, 87736220412, 87891220517, 87864220509, 87738220412
Distribution pattern: FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA
Derived failure modes
-
Unknown
A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device