Getinge became aware of an issue with one of our devices ¿ lucea 100.The provided problem description included a statement for damaged top and bottom covers.Additionally a cracked covers with missing parts were identified.Fortunately, no injury has been reported due to mentioned issue however we decided to report it based on the potential as such damage could have led to particles detachment, which consequently might become a source of contamination of the sterile field.It was established that when the event occurred, the surgical light did not meet its specification as it was damaged and particles were missing, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.Given the circumstances 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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