This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on device return investigation results physical damages to the device were most likely due to user mishandling.Laser damage to the distal tip is a known phenomenon that may occur from direct or reflected energy by misfiring of laser during a procedure as stated on the ifu (instruction for use) and as a preventive measure, the user manual states: keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active.Olympus will continue to monitor complaints for this device.
|