Safety Alert for Proximity multi-ignition automatic linear cutter. Proximate Multiple-Fire Single-Use Automatic Linear Cutters: (1) TCT Series, (2) TLC Series, (3) TVC Series

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ethicon Endo-Surgery Inc A Johnson 163 Johnson Co [149225], 4545 Creek Rd, Cincinnati OH 45242 USA; representante de vendas da Ethicon Endo-Surgery.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Ecri reports that the safety lock mechanism of the above-mentioned linear cutters can be activated prematurely, interfering with the operation of the equipment. the safety lock is intended to prevent the appliance from continuing to operate after the staple cartridge has been used. however, the movement or absence of a small rotating tab that must be positioned over the blade channel in the staple cartridge causes the lock mechanism to be triggered prematurely. the mechanism stops the machine running quickly after the linear cutter starts inserting staples from a new cartridge or a full cartridge. the problem of partial activation prolongs the surgery, can result in the removal of greater amount of tissue, besides also increasing the chances that patient presents unwanted reactions.
  • Action
    Contact your Ethicon Endo-Surgery sales representative to determine if you have affected linear cutters or rechargeable cartridges. ECRI recommends that you follow the following precautions until you have verified that you no longer have any affected products in your inventory. (1) Inspect linear cutter boxes for any signs of damage that appear to be a result of a fall or other excessive force. Return any damaged box to Ethicon Endo-Surgery at the address mentioned, or inspect the linear cutters carefully before use to ensure that the faucet is in the proper position. (2) Inspect the plastic clamp retainer on all TCT, TLC, and TVC series of linear cutters before using them to verify that it is an original design clamp retainer or a modified design clamp retainer. If the cleat retainer only covers the cleats of the cleats, you have a retainer of original design cleats. Examine the turntable to make sure it is in the "closed" position by looking into the cutter blade channel or by turning the staple cartridge upside down and making sure that the orange turntable is positioned over the channel. If so, the linear cutter can be used. If the orange tab is not visible over the channel, the linear cutter will fail during use. Replace the staple cartridge with the cartridge refilled, or use another linear cutter. If the retainer extends past the staple cartridge staples and prevents the cutter blade from moving, you have a staple retainer corrected, that is, modified (3) Inspect staple refill cartridges of the TCT, TLC and TVC before inserting them into the linear cutter. Do not use any refill cartridge in which the turntable clip is missing or not on the channel. (4) Return any defective linear cutter or defective cartridge to Ethicon Endo-Surgery at the above address so that the value is credited to subsequent purchases. For more information contact your local representative or directly Carlos Fornazier at Tecnovigilância of ANVISA by e-mail tecnovigilâ or by phone 0xx61-4481331 ..