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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 Technologysee related information
Date Initiated by FirmMarch 26, 2018
Create DateMay 15, 2018
Recall Status1 Terminated 3 on April 08, 2020
Recall NumberZ-1889-2018
Recall Event ID 79801
510(K)NumberK032676 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Code Information Lots P4T686 P4T79A P4T99K P4TC30 P4TD2D R40191 R40223 R4045J R4054D R40642 
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Blue Ash OH 45242-2803
For Additional Information ContactEthicon 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
ActionThe 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 Commerce11074
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = GCJ
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