Medical device manufacturer, Orascoptic, has issued a medical device safety alert concerning its Endeavour Light System [Part No.: 910114-X; Serial no.: 78100100 to 78113815].
The manufacturer is informing end users of a possible light output issue with the Endeavour Light System, which was shipped to place of distribution from November 2011 through August 2013.
The manufacturer discovered that intermittent to no light output may occur without proper placement of the spiral temple clip that was provided with the initial purchase. This clip is a critical component of the Endeavour light system that should be used to secure the cable to the temple arm of the frame.
As a preventive measure, a complimentary spiral temple clip is offered to end users along with instructions on how to place the clip as a means to secure the cable to the temple arm of his/her loupes and prevent strain on the cable that allows power to reach the headlight LED.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 December 2013