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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Endosee Cannula

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  Class 2 Device Recall Advanced Endosee Cannula see related information
Date Initiated by Firm December 13, 2019
Create Date January 10, 2020
Recall Status1 Terminated 3 on May 11, 2021
Recall Number Z-0798-2020
Recall Event ID 84443
510(K)Number K190639  
Product Classification Hysteroscope (and accessories) - Product Code HIH
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.
Code Information Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information Contact Customer Service
203-601-9818
Manufacturer Reason
for Recall		 Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
FDA Determined
Cause 2		 Other
Action 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
Quantity in Commerce 460
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HIH and Original Applicant = CooperSurgical, Inc.
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