Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).Maquet sas became aware of an incident with surgical light g8 evolution device.It was stated that during surgery two spring arms hit each other and the cover of one of them fell down.The cover did not fall in the operating field and the surgery could be completed, there was no injury or contamination reported.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the event.At the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that this is a single, isolated case and that the reported scenario has never lead to serious injury or worse.The manufacturer has performed an investigation for that case.According to the results of the investigation there are two factors that could cause a fall of plastic cover.Potential root causes of the fall might be due to an incorrect attachment of the dust cover or a detachment might happened due to repeated collisions.Collisions could occur during handling of the device, however they are considered as an inappropriate use of the device by user.The operating manual includes the instructions to pre-position the arms prior to use in order to prevent damages.To prevent any other similar case, maquet sas recommends in g8 evolution user manual 0138101 nu en es ed.1g how to properly position the surgical light before the procedure.We believe that if the manufacturer recommendation in the ifu would have been followed the incident would have been avoided.Given the circumstances and the fact that this complaint is considered to be a single, isolated event we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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