The spring arm which detached was installed by trumpf medical on (b)(6) 2021 as a spare part.The device was inspected by a trumpf medical field service technician.It was determined that the snap ring, which secures the spring arm at the central axis, became loose as a result of an installation failure on (b)(6) 2021, which allowed the spring arm to separate from the central axis.The engineering investigation indicated if the snap ring is not installed correctly or is not properly seated in the groove it can become loose.Then, over time and through normal use, the spring arm can slowly descend from its original position and the spring arm can separate from the central axis.Other effects of improper snap ring installation include difficulty moving the spring arm, a noticeable gap between the spring arm and central axis, and the potential for a loss of light.These effects would be evident prior to the spring arm becoming dislodged from the central axis.The root cause was traced to an installation failure of the snap ring.Several evaluations by ondal medical systems and trumpf medical concluded that if the snap ring is installed properly, the snap ring will not come out of the groove during the lifetime of the device.Based on this, no further actions are necessary.
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