It was reported that, during a cori installment, the camera's led indicator was flashing red, indicating a fatal error.The system was unable to detect the camera even after they verified all the connections.The system was not able to detect the camera, so they were unable to complete camera diagnostics.No patient was involved.No other complications were reported.
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H6: the real intelligence tracking camera, part number rob10025, serial (b)(6) and intended to be used for treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was not confirmed.No issues found with camera upon troubleshooting.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is improper connection between console and camera.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.D10: add concomitants.
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