International safety notice
Alert 2584 (Technovigilance) - Auto Suture do Brasil Ltda - Cargo for Universal Endo Gia Stapler with Tri-Staple Technology Device may fail to form a staple line in the tissues, which may result in bleeding or leakage.
Brazil / Anvisa · BRA · Jun 4, 2018
Key facts
| Title | Alert 2584 (Technovigilance) - Auto Suture do Brasil Ltda - Cargo for Universal Endo Gia Stapler with Tri-Staple Technology Device may fail to form a staple line in the tissues, which may result in bleeding or leakage. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Load for Endo Gia Universal Stapler with Tri-Staple Technology Technical Name: Clamps ANVISA registration number: 10349000296 Risk Class: III Affected model: EGIA45AMT; Affected serial numbers: N7L1057KX; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AUTO SUTURE DO BRASIL LTDA CNPJ 01645409000128 AV JORNALISTA ROBERTO MARINHO 85 11º ANDAR CEP 04675010 SÃO PAULO SP TEL 11 21829200 EMAIL TECNOVIGILANCIACOVIDIENCOMNATALIAJMAIAMEDTRONICCOM FABRICANTE DO PRODUTO COVIDIEN LLC ESTADOS UNIDOS DA AMÉRICA 15 HAMPSHIRE STREET MANSFIELD MA 02048 ESTADOS UNIDOS |
| Models | EGIA45AMT, N8A0146KX, N7L0551KX, EGIA60AXT, EGIA45AXT, N7L0521KX, EGIA45AVM, N7L0974KX, N7M0486KX, 10349000296, N7L1038KX, N8A0363KX and 6 more |
| Date | Jun 4, 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