Alerta De Seguridad para ROBÓTICO SURGICAL SYSTEM DA VINCI. Instrument: TISSUE CURVAMONOPOLAR HOT SHEARS. Anvisa Registry: 10302860146.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

The product will be collected by the company. Precautions and warnings for using the EndoWrist Monopolar Curve Scissors until recoil is performed: (1) Do not apply power when the scissor tips are not in contact with tissue. Power should not be applied to an instrument when it is not in direct contact with the tissue (referred to as "shoot into the air"). Additionally, do not use an electrosurgical instrument to apply cauterization to any other instrument; (2) Be aware of critical anatomical elements in contact with the instrument during the activation of energy. While activating monopolar energy, be aware of anatomy elements that are in contact with the handle or stem of the instrument. The instrument shall not be used as a retractor during the application of energy; (3) Examine the surgical field. In the course of each surgical procedure, surgeons should examine the surgical field, especially where the distal end of the instrument stem may have been in contact with tissues. Also examine the tissues surrounding the main surgical field, including the "below" or "behind" areas of the cannula and the endoscope, which are normally out of sight; (4) Take into consideration the state of health of the patient. Before using monopolar cauterization in a surgical procedure, consider factors that may make elements of a patient's anatomy and tissues more susceptible to injury resulting from the application of cauterization (eg, patients who have received radiation therapy prior to surgery); (5) Use only one validated electrosurgical unit (SEU). ESUs that have been validated for use with EndoWrist monopolar instruments, including MCS, are listed in the Instrument and Accessories User Manual section 3.1; (6) Do not exceed the maximum settings for monopolar cauterization. The guidelines governing the maximum settings for cauterization are listed in section 3.3, ESU Definitions and Power Activation Cables in the Instrument and Accessories User's Guide. If the maximum settings for cauterization are exceeded, this will exceed the 3 kV limit of the instrument, which could result in arcing and thermal injury at other locations. The User's Manual also indicates that the user should set the power to the lowest value possible for adequate hemostasis. See general precautions and warnings in the Instruments and Accessories User Manual; (7) See general precautions and warnings in sections 2.1, 2.2, 4.1 and 4.2 of the Instrument and Accessories User's Manual.