Device product
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.
Z-0798-2020
Product summary
- Event
- Event 84443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 460
- Official record key
device-enforcement:Z-0798-2020
Official wording
Reason: Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Code information: Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020
Distribution pattern: US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None
Derived failure modes
-
Unknown
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).