International safety notice
Alert 2545 (Technosurveillance) - Olympus Ureterorenofibroscope Risk of the device causing tissue trauma, including ureter perforation.
Brazil / Anvisa · BRA · Apr 17, 2018
Key facts
| Title | Alert 2545 (Technosurveillance) - Olympus Ureterorenofibroscope Risk of the device causing tissue trauma, including ureter perforation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Ureterorenofibroscope Technical name: Ureterorenofibroscope ANVISA registration number: 80124630193 Risk class: II Affected model: URF-P6/P6R Affected serial numbers: 2613119, 2613237,2613239, 2612933, 2612936, 2612947, 261H189,2613101, 2612937, 2613240, 2613102, 2613844, 2613861, 2613846, 2613847, 2613848, 2613845, 2613864, 2613866, 2612931, 2613077, 2613843. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO OLYMPUS OPTICAL DO BRASIL LTDA CNPJ 04937243000101 RUA DO RÓCIO 430 2º ANDAR VILA OLIMPIA SÃO PAULO SP TEL 11 30466400 RAMAL 6465 EMAIL QUALIDADEBRASILOLYMPUSCOM FABRICANTE OLYMPUS MEDICAL SYSTEMS CORP 2951 ISHIKAWA CHO HACHIOJISHI TOQUIO JAPÃO TELEFONE 81042 6422111 EMAIL MARIKO1ARAIOTOLYMPUSCOJP |
| Models | 261H189, 2612937, 2613844, 2612931, 2613848, 2613866, 2613102, 2613239, 2613846, 2612936, 2613237, 2612933 and 12 more |
| Date | Apr 17, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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