International safety notice
Alert 2787 (Technovigilance) - H. Strattner e Cia Ltda - Refill for Harmonic Ace Forceps, Curved, 8 mm, for da Vinci Intuitive Surgical Robotic Surgical System - Possibility of damage to the sterile packaging of the product.
Brazil / Anvisa · BRA · Jan 25, 2019
Key facts
| Title | Alert 2787 (Technovigilance) - H. Strattner e Cia Ltda - Refill for Harmonic Ace Forceps, Curved, 8 mm, for da Vinci Intuitive Surgical Robotic Surgical System - Possibility of damage to the sterile packaging of the product. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: da Vinci Intuitive Surgical Robotic Surgical System Technical Name: System for Endoscopic Surgery ANVISA registration number: 10302860146 Risk Class: III Affected model: 400272 - Refill for Harmonic Ace Forceps, Curved, 8 mm, Box with 05 Units, Sterile and Single-Use Da Vinci Robotic - Intuitive Surgical, Models IS2000 AND IS3000 Affected serial numbers: See attachment "List of serial numbers at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO H STRATTNER E CIA LTDA CNPJ 33250713000162 RUA RICARDO MACHADO 904 VASCO DA GAMA RIO DE JANEIRO RJ TEL 21 21211300 EMAIL QUALIDADESTRATTNERCOMBR FABRICANTE DO PRODUTO INTUITIVE SURGICAL INC 1266 KIEFER ROAD SUNNYVALE CALIFORNIA 94086 ESTADOS UNIDOS DA AMÉRICA |
| Models | IS2000, IS3000, 10302860146, 400272 |
| Date | Jan 25, 2019 |
| 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