The subject telescope was returned to the service center (oci) for evaluation of the reported "sharp edges at the tip and black out lens." upon inspection, it was confirmed that the scope had no image due to optical fiber breakage, and the outer tube was bent.The distal tip of the outer tube is bent however, no sharp edge at the tip was observed.Additionally, there is dirt in objective unit and moisture in the optical system were also noted.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on the device inspection result, damage that occurred to the device was most likely due to user mishandling.The legal manufacturer will continue to monitor the field performance of this device.As stated on the ifu (instruction for use) and as a preventive measure, the user manual indicates, "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.".
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