Product name: VINCI ROBOTIC SURGICAL SYSTEM - INTUITIVE SURGICAL /// ANVISA registry number: 10302860146 /// Risk class: III /// Affected model (s): Da Vinci Surgical System and Surgical System Vinci Xi, but in Brazil there is only the commercialization of the da Vinci model Si.///Affected serial number (s): All series numbers manufactured until November 2015, but in Brazil we only have the following numbers of series: SH2344; SH2341; SH2362; SH2312; SH2339; SH2360; SH2338; SH2361. 의 안전성 경고

Safety alert

1940

2016-04-06

Brazil

ANVISA

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

"it has been reported that the flash memory cards used in the touchpad on the patient arm carriage and on the surgeon's console can corrupt the data if the system has a sudden drop in power or is turned off and reconnected within a short period of time. time. in some cases, the failures can be recovered, but in others the same will not be possible, preventing the use of the system. ".

field action no. TECNOVIGI / AC / 01-2016. Recommendations to users and patients: This Field Action aims to inform customers about the possible malfunction of a component of the equipment and to perform the component exchange, voluntarily. It has been reported that the memory cards used in the touchpad may corrupt if the system has a sudden drop in power or is turned off and reconnected within a short period of time. In some cases, the failures can be recovered, but in others the same will not be possible, preventing the use of the system. In case of an error on the touchpad, proceed according to standard company guidelines.