Events

Recall of CONICAL TIP SPIKE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    28492
  • Event Risk Class
    II
  • Event Initiated Date
    2010-02-09
  • 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
    The manufacturer has received one complaint that the trocar tip had fallen off during a surgical procedure. as a consequence the tip needed to be removed in an additional surgical procedure. the trocar tip was detached from the trocar shaft due to a fracture in the weld seam between the tip and shaft.

Device

CONICAL TIP SPIKE
  • Model / Serial
    Model Catalog: A5949 (Lot serial: 084W); Model Catalog: A5821 (Lot serial: 075W); Model Catalog: A5949 (Lot serial: 081W); Model Catalog: A5949 (Lot serial: 07YW); Model Catalog: A5949 (Lot serial: 07XW); Model Catalog: A5949 (Lot serial: 078W); Model Catalog: A5949 (Lot serial: 077W); Model Catalog: A5949 (Lot serial: 076W); Model Catalog: A5949 (Lot serial: 075W); Model Catalog: A5948 (Lot serial: 081W); Model Catalog: WA58341L (Lot serial: 081W); Model Catalog: A5821 (Lot serial: 081W); Model Catalog: A5948 (Lot serial: 07YW); Model Catalog: WA58341L (Lot serial: 07YW); Model Catalog: A5821 (Lot serial: 07YW); Model Catalog: A5948 (Lot serial: 07XW); Model Catalog: WA58341L (Lot serial: 07XW); Model Catalog: A5821 (Lot serial: 07XW); Model Catalog: A5948 (Lot serial: 078W); Model Catalog: WA58341L (Lot serial: 078W); Model Catalog: A5821 (Lot serial: 078W); Model Catalog: A5948 (Lot serial: 077W); Model Catalog: WA58341L (Lot serial: 077W); Model Catalog: A5821 (Lot serial: 077W); Model Catalog: A5948 (Lo
  • Product Description
    OLYMPUS TROCAR SPIKES (CONICAL TIP)
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.