Events

Recall of DA VINCI SURGICAL SYSTEM DRAPE

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
    80214
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-20
  • 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
    Tears: through standard product quality testing it was noted that the adhesive labels intended to keep the drape folded were found in some instance unintentionally overlapping multiple folds of the drape. cloudy/waxy appearance: through customer feedback intuitive surgical found that some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance.

Device

DA VINCI SURGICAL SYSTEM DRAPE
  • Model / Serial
    Model Catalog: 420258-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420273-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420022-02 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420015-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420026-01 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420291-03 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 420017-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 400027-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400016-04 (Lot serial: >10 numberscontact mfg); Model Catalog: 400015-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420290-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420279-03 (Lot serial: >10 numberscontact mfg); Model Catalog: 420281-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420273-02 (Lot serial: >10 numberscontact mfg); Model Catalog: 420258-01 (Lot serial: >10 numberscontact mfg); Model Catalog: 420256-01 (Lot serial: >10
  • Product Description
    Da Vinci Surgical System Drape
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.