Device product
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Z-2331-2024
Product summary
- Event
- Event 94804
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-2331-2024
Official wording
Reason: Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Code information: Model No. ASX9/130; UDI# 00850002332278; Lot No. 7336314.
Distribution pattern: Domestic: NY, OH, & DC.
Derived failure modes
-
Unknown
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.