Events

Safety Alert Or Field Safety Notices for Optima XL stubby handle

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Timesco of London Ltd.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/045
  • Event Number
    CON2031338
  • Date
    2007-06-04
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2031338
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Poor contact between timesco stubby handles and timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation. timesco believe that there may be a possibility that the electrical contact on the stubby handle may become bent out of position when used with an early design of callisto disposable blade (pre november 2003), which depressed the bulb slightly more than the current timesco callisto single-use design and other timesco reuseable blades. this could have resulted in the bulb failing to be lit if the handle was subsequently used with any current timesco design blade. the stubby handle electrical contact is shown in figure 1 below. timesco sent a letter to inform customers of this issue in february 2007 and, as a precautionary measure, they implemented a redesigned contact mechanism in the stubby handle in january 2007 figure 1. stubby handle electrical contact.
  • Action
    Identify all stubby handles that are currently in use. Regularly check that the contact spring is adequately elevated to make good contact with the laryngoscope bulb when the bulb is depressed. Check the function of the handles before each use.

Device

Optima XL stubby handle
  • Model / Serial
  • Product Description
    Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Models: 3000.308.10 and 3000.308.10T. A Timesco stubby handle is a short length laryngoscope handle often used for difficult intubations. Callisto blades are also manufactured by Timesco. Instructions for use are supplied with each stubby handle.
  • Manufacturer
    Timesco of London Ltd

Manufacturer

Timesco of London Ltd
  • Manufacturer Parent Company (2017)
    Timesco
  • Source
    MHRA