—#107792

Product

ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw, Model # NSLG2C45. 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.

FDA product code: LFL — Instrument, Ultrasonic Surgical
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K112033
Affected lot / code info: Product Code 00NSLG2C35, Lot #, H44V7M, Exp Date, Oct-2013, Lot # H44V7N, Exp Date, Oct-2013, Lot # H44V7P, Exp Date, Oct-2013, Lot # H44X9L, Exp Date, Nov-2013, Lot # H44X9M, Exp Date, Nov-2013, Lot # H44X9R, Exp Date, Nov-2013, Lot # H44Z3R, Exp Date, Nov-2013, Lot # H44Z4C, Exp Date, Nov-2013, Lot # H44Z54, Exp Date, Nov-2013, Lot # J4A085, Exp Date, Dec-2013 & Lot # J4A134, Exp Date, Dec-2013; Product Code 00NSLG2C45, Lot #, H44W25, Exp Date, Oct-2013, Lot # H44W26, Exp Date, Oct-2013, Lot # H44W27, Exp Date, Oct-2013 & Lot # J4A19D, Exp Date, Dec-2013

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-01-26
Posted by FDA: 2012-03-21
Terminated: 2013-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107792. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.