Getinge became aware of an issue with surgical light ¿ powerled ii.As it was stated, down tube cap came loose and fell off into sterile field during case.There was no injury reported however we decided to report the issue in abundance of caution as any falling parts might cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the down tube cap shouldn¿t be in a state in which it can detach, and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.It was established that the detachment of the down tube cap was caused by an improper fitting due to the protrusion of earth fixing head screw.It was probably mounted upside down during the installation.Moreover, it appeared that the protrusion of the earth fixing head screw restricted the fitting of the inner part of the cover in the suspension axle.The inner part of the cover was probably cut to avoid the contact with the protrusion of the head screw and then the cap wasn¿t able to be attached properly.Therefore, we conclude that the root cause of the issue is related to the installation process.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.We believe that our devices are performing correctly on the market.
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