Class 2 Device Recall Endopath Xcel with Optiview Technology

• Date Initiated by Firm: March 26, 2018
• Create Date: May 15, 2018
• Recall Status: Terminated on April 08, 2020
• Recall Number: Z-1886-2018
• Recall Event ID: 79801
• 510(K)Number: K032676
• Product Classification: Laparoscope, general & plastic surgery - Product Code GCJ
• Product: 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
• Code Information: Lots P4T745 P4T88Y P4T906 P4T91H P4TA60 P4TC8M P4TD0G P4TD2K R40015 R4011E R4025E R4035E R4042Z R4047X R4065E
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery Inc; 4545 Creek Rd; Blue Ash OH 45242-2803
• For Additional Information Contact: Ethicon Customer Support Center; 877-384-4266
• Manufacturer Reason for Recall: Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
• FDA Determined Cause: Process control
• Action: The firm notified customers and distributors by letter on March 26, 2018, and March 27, 2018, respectively. Customers were informed of the issue and potential risk of prolonged surgery or introduction of minute particles. Customers were instructed to: 1. Examine your inventory immediately to determine if you have any products subject to this recall on hand and quarantine such product(s). 2. Remove the products subject to this recall from your inventory and communicate the issue to all relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any of the devices subject to this recall have been forwarded to another facility, please contact that facility to arrange return. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this recall. 4. Customers are required to return all unused devices subject to this recall that are in their inventory immediately. 5. To return unused devices subject to this recall photocopy the completed BRF, place it in the box with the subject product(s), and affix the pre-paid authorized shipping label included with this recall notification letter. Distributors were instructed to: 1. Examine your inventory immediately to determine if you have the product lot subject to this recall on hand and quarantine such product(s). 2. Remove the product lot subject to this recall and communicate the issue to all relevant materials management personnel, or anyone else in your facility who needs to be informed. 3. Complete the Business Reply Form confirming receipt of this notice and fax or email it to Stericycle at 1-888-965-5794 or Ethicon3546@stericycle.com within three (3) business days. Please return the BRF even if you do not have the product lot subject to this rec
• Quantity in Commerce: 14873
• Distribution: Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
• 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 = GCJ and Original Applicant = ETHICON ENDO-SURGERY, INC.