Device product
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Z-1295-2025
Product summary
- Event
- Event 96216
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 623 units
- Official record key
device-enforcement:Z-1295-2025
Official wording
Reason: Possibility for the obturator to break (separate).
Code information: Catalog Number: (1) ASX15/60 (2) ASX15/80; UDI-DI: (1) 00850002332254, (2) 008500023332247; Lot No. (1) All unexpired lots, (2) All unexpired lots.
Distribution pattern: US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
Derived failure modes
-
Unknown
Possibility for the obturator to break (separate).