Events

Recall of MEGATIP NON-STICK CAUTERY TIP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEGADYNE MEDICAL PRODUCTS 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
    32388
  • Event Risk Class
    II
  • Event Initiated Date
    2003-10-10
  • 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
    On dec 16 2002 confirmed that the distal end of the megatip cautery tip broke off during a laparoscopic procedure and was not retrieved by the surgeon. investigation revealed stress cracks in the tip.

Device

MEGATIP NON-STICK CAUTERY TIP
  • Model / Serial
    Model Catalog: 0600 (Lot serial: CAT 0600: 10766 10951 20997); Model Catalog: 0600M (Lot serial: CAT 0600: 10766 10951 20997); Model Catalog: 0600 (Lot serial: AND 21075); Model Catalog: 0600 (Lot serial: CAT 0600M: 20814); Model Catalog: 0600M (Lot serial: AND 21075); Model Catalog: 0600M (Lot serial: CAT 0600M: 20814)
  • Product Description
    MEGATIP NON-STICK CAUTERY TIP
  • Manufacturer
    MEGADYNE MEDICAL PRODUCTS INC

Manufacturer

MEGADYNE MEDICAL PRODUCTS INC
  • Manufacturer Address
    DRAPER
  • Source
    HC