On (b)(6) 2019 getinge became aware of an issue with lucea 10 light.As it was stated, the connection between main tube and suspension arm was cracked.There was no injury reported.Taking into consideration the worst case scenario which is the detachment of examination light, we decided to report the issue based on the potential.
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Getinge became aware of an issue with one of the lucea 10 light devices.It was reported to us initially that the suspension arm was showing early signs of breakage, which could consequently lead to detachment from the main tube.There was no injury reported, however we decided to report the issue based on the received indication and in abundance of caution - as a situation in which a suspension arm would actually detach may lead to serious injury.It was established that when the event occurred, the light did not meet its specification as it has been found that breakage of the weld occurred ¿ and this confirms that there was technical deficiency of the device (out of specification) and it contributed to event.In the time when the event occurred the device was not used for patient treatment.The device involved in this event has been identified as a lucea 10 model with the serial number (b)(4) and catalog number ard568602971.The manufacturing date of the device is 21st of june, 2019.Device history record was reviewed and no anomalies were found.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.Performed evaluation of returned parts revealed that although the cylinder pin, preventing the tube from falling out, was in its dedicated place however it has been broken in two places, what resulted in its function to be lost.This, in the worst case scenario, could cause the tube being completely uncoupled from the main axis and prevented from falling only by the harness cable.The root cause analysis was performed by the subject matter expert and supported with review of faulty parts received from the market.The conclusion is pointing to misuse being the main cause of pin breakage.When the arm of the device (oriented 90o to the main arm) is moved without loosening the clamping knob to release the pivot as described in the user manual nu_lucea_1001701 page 29 (positioning the light), a strong shearing effect is applied on the cylinder pin.With repetitive motions like this over time, it is probable that the pin can break.We believe that this type of our devices are performing correctly in the market.We also believe that if the manufacturer recommendation as described in the instructions for use and pertaining to avoidance of collisions and checks before use would have been followed the incident could have been avoided.
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