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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath Xcel with Optiview Technology

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  Class 2 Device Recall Endopath Xcel with Optiview Technology see related information
Date Initiated by Firm March 26, 2018
Create Date May 15, 2018
Recall Status1 Open3, Classified
Recall Number Z-1888-2018
Recall Event ID 79801
510(K)Number K032676  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Code Information Lots P4T636 P4T63G P4T689 P4T708 P4T86Z P4T882 P4T89N P4T97L P4T994 P4TA0T P4TA17 P4TA55 P4TA70 P4TA7R P4TC53 P4TC7X P4TC87 P4TC8U P4TC93 P4TD1Y R4003L R40048 R4005Z R4010L R4012F R40142 R4020P R4021H R4027N R4042X R4045N R4046X R4054H 
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 2
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 95233
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = ETHICON ENDO-SURGERY, INC.
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