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.
- Company
- Coopersurgical, Inc.
- Recall Initiated
- December 13, 2019
- Terminated
- May 11, 2021
- Recall Number
- Z-0798-2020
- Quantity
- 460
- Firm Location
- Trumbull, CT
Reason for Recall
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Distribution
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
Lot / Code Info
Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020
Root Cause
Other
Action Taken
On December 13, 2019 the firm sent out letters via Fed-Ex stating the following: URGENT: MEDICAL DEVICE RECALL COOPERSURGICAL ENDOSEE CANNULA Dear Valued CooperSurgical Customer, CooperSurgical is issuing a Medical Device Recall for two lot numbers (268748 & 269360) of its ENDOSEE Advance Cannula (CooperSurgical part number: ESPX5) (the Product), because the finished seal (opposite the chevron seal) of the sterile pouch may be compromised, thereby increasing the risk of infection. The Product is an Ethylene Oxide (ETO) sterilized, single-use, disposable cannula, which is sold in 5 Units/box. Each Unit contains an individually wrapped cannula and an individually pouched endometrial suction pipet curette. The compromised seals were detected during a complaint investigation. No adverse events have been reported to CooperSurgical due to this potential issue. This recall affects 2,285 units of the 2 lot numbers shown above, which were manufactured in April and August 2019. We have identified the root cause, and a corrective action has been initiated to prevent future recurrence. Our records indicate that you have purchased the affected Product from CooperSurgical. As indicated in the Instructions-for-Use (IFU), each package should be handled with care and inspected for damage, including the seal area, prior to use. A Product is acceptable for use if it is visually confirmed that the pouchs seal is intact. Please discontinue use of and quarantine Products with any packaging irregularities, complete the attached Acknowledgement and Receipt Form, and return it to CooperSurgical. Once we receive the Acknowledgement Form, we will arrange for Product replacements and returns of affected Product. The replacement Products will be charged at the same price as the original order and your account will be credited back once the affected products are returned to CooperSurgical. If you do not have affected Product in inventory, please use the same enclosed Form to