Events

Recall of DA VINCI S SURGICAL SYSTEM - CONTROL FOR ENDOSCOPIC INSTRUMENTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MINOGUE MEDICAL INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    84824
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Patient side cart battery boxes (bpm) returned from the field revealed that in some rare charging conditions the battery can overheat. overheating has the potential to result in the battery bulging and the release of internal battery gases into surrounding air.

Device

DA VINCI S SURGICAL SYSTEM - CONTROL FOR ENDOSCOPIC INSTRUMENTS
  • Model / Serial
    Model Catalog: 371268-02 (Lot serial: SH1319); Model Catalog: 371268-02 (Lot serial: SH1184); Model Catalog: 371268-02 (Lot serial: SH1163); Model Catalog: 371268-02 (Lot serial: SH1104); Model Catalog: 371268-02 (Lot serial: SH0370); Model Catalog: 371268-02 (Lot serial: SG359); Model Catalog: 371268-02 (Lot serial: all lots w part#371268-02); Model Catalog: 371268-02 (Lot serial: SH0260); Model Catalog: 371268-02 (Lot serial: )
  • Product Description
    Da Vinci S Si and Si-e - battery box
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.