“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
IS4000-XI, IS3000-SI and SI-E, concerning the EndoWrist sealant, references 410322 and 480322.
Product Description
The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient car and a vision car, it also includes the endoscopes and instrumentosendowrist.
The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVESURGICAL endoscopic instruments during urological surgical procedures, general laparoscopic surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures . The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon console, a patient car and a vision car, including endoscopes and endowrist instruments.
The INTUITIVE SURGICAL endoscopic instrument control system is designed to assist you in the accurate control of INTUITIVE SURGICAL endoscopic instruments during urological surgical procedures, laparoscopic general surgical procedures, laparoscopic gynecological surgical procedures, thoracoscopic general surgical procedures and thoracoscopic assisted cardiotomy procedures. The system can also be used with adjunctive mediastinotomy to perform coronary artery bypass during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified doctors in an operating room. Commercial presentation: the DA VINCI system includes a surgeon's console, a patient's car and a vision car, it also includes ENDOWRIST endoscopes and instruments.
The purpose of the INTUITIVE SURGICAL endoscopic instrument control system is to help accurately control INTUITIVE endoscopic instruments, such as rigid endoscopes, endoscopic dissectors and incisors, scissors, scalpels, forceps / clamps, needle handling tools, endoscopic retractors, stabilizers, accessories for electrocautery and for endoscopic manipulation, for example to hold them, cut them, perform a blunt or incisal excision, bring them closer, ligate them, electrocauterize them and suture them during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopic assisted cardiotomy interventions. The system can also be used with adjoining mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for use in adults and pediatrics. It is designed to be used by qualified physicians in surgical environments, using the representative and specific procedures described in the instructions for use. INTUITIVE SURGICAL's endoscopic instrument control system has been successfully used, among others, in the following procedures; • radical prostatectomy, pyeloplasty, cystectomy, nephrotomy, urethral reimplantation • cholecystectomy, Nissen fundoplication, Heller's myotomy, gastric deviation, donor nephrotomy, adrenalectomy, splenectomy, and intestinal resection. • hysterectomy, myomectomy, sacrocopopaxy • mobilization of the internal mammary artery, ablation of cardiac tissue • repair of the mitral valve, endoscopic closure of atrial septal defects, • breast anastomosis of the left anterior descending coronary artery for cardiac revascularization with adjunctive mediastinotomy -representative pediatric: the The INTUITIVE SURGICAL endoscopic instrument control system has been successfully used, among others, in the following pediatric surgical procedures: • pyeloplasty,