Alerta De Seguridad para Proximity multi-ignition automatic linear cutter. Proximate Multiple-Fire Single-Use Automatic Linear Cutters: (1) TCT Series, (2) TLC Series, (3) TVC Series

Safety alert

210

2000-11-17

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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.

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 tecnovigilância@anvisa.gov.br or by phone 0xx61-4481331 ..