Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Société-mère du fabricant (2017)
  • Source
    USFDA