Block h6: device code a06 captures the reportable event of loss of visualization inside the patient.Block h10: with all the available information, boston scientific concludes that the reported allegation of loss of visualization was unable to be confirmed.Upon receipt of this device, the controller was thoroughly analyzed.Visual analysis identified finish damage to the top cover, front panel, and bottom of housing.During functional testing, the device performed as intended.The reported observation was not able to be duplicated or confirmed.Based on all gathered information, the probable cause selected for loss of visualization is no problem detected, which indicates that the device problem was not confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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