| Class 2 Device Recall ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw | |
Date Initiated by Firm | January 26, 2012 |
Date Posted | March 21, 2012 |
Recall Status1 |
Terminated 3 on February 15, 2013 |
Recall Number | Z-1246-2012 |
Recall Event ID |
61314 |
510(K)Number | K112033 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code LFL
|
Product | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969
The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. |
Code Information |
Product Code 00NSLG2S14, Lot #, H44Z5R, Exp Date, Nov-2013; Product Code 00NSLG2S25, Lot #, H44Z57, Exp Date, Nov-2013 & Lot # J4A28X, Exp Date, Dec-2013 |
Recalling Firm/ Manufacturer |
Ethicon Endo-Surgery Inc 4545 Creek Rd Cincinnati OH 45242-2803
|
For Additional Information Contact | Thomas A. Morris 513-337-3419 |
Manufacturer Reason for Recall | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button:
(i) Continuous Activation: The ENSEAL device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3).
(ii) No Activation |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to:
Ethicon Endo-Surgery
ATT: ENSEAL G2 Recall
4545 Greek Road
Cincinnati, Ohio 45242
Customers were instructed to choose one of the following response options:
Return the Business Reply Form to their sales representative
Call 1-800-873-3636, Option 6
Fax the BRF to 1-513-337-4138
For any questions regarding this recall call 513-337-3419. |
Quantity in Commerce | 84 pieces |
Distribution | Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey. |
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 = LFL
|
|
|
|