International safety notice
Alert 2594 (Technosurveillance) - Intutive Surgical Brasil Importação e Comércio de Equipamentos Cirúrgicos Ltda - Blue refill for stapler 45mm Xi Possible lack of blade mechanism component results in tissue cutting failure.
Brazil / Anvisa · BRA · Jun 27, 2018
Key facts
| Title | Alert 2594 (Technosurveillance) - Intutive Surgical Brasil Importação e Comércio de Equipamentos Cirúrgicos Ltda - Blue refill for stapler 45mm Xi Possible lack of blade mechanism component results in tissue cutting failure. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Blue refill for 45mm Xi stapler Technical Name: Endoscopic Surgery System ANVISA registration number: 81166920001 Risk Class: III Affected model: 48645B-03 and 48445G-03 Affected serial numbers: PN 48645B-03: lots XXX160202 XXX180107/ PN 48445G-03: XXX151014 and XXX160601 XXX180221 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO INTUTIVE SURGICAL BRASIL IMPORTAÇÃO E COMÉRCIO DE EQUIPAMENTOS CIRÚRGICOS LTDA CNPJ 12506008000103 RUA PADRE MARINHO 49 SALAS 104 E 105 BAIRRO SANTA EFIGENIA BELO HORIZONTE MG TEL 55 11 964299876 EMAIL EMILENEMARTINSINTUSURGCOM FABRICANTE DO PRODUTO INTUITIVE SURGICAL INC 1266 KIFER RD SUNNYVALE CA 94086 ESTADOS UNIDOS |
| Models | XXX160202, XXX151014, 48445G-03, XXX180221, 48645B-03, XXX180107, XXX160601, 81166920001 |
| Date | Jun 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1