The device was evaluated at ode.As a result of the evaluation, the following was confirmed.The coating on the insertion tube was peeled off.The electrical connector and ultrasonic cable connector were dirty.There was no radius of the forceps elevator wire.The device was last repaired on (b)(6) 2021.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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This supplemental report is being submitted to provide additional information.From the information provided, olympus medical systems corp.(omsc) confirmed that the adhesive around the acoustic lens surface at the distal end was peeled off.Since the device was manufactured on october 5, 2017, it is highly unlikely that the adhesive would come off due to aging.Therefore, it is possible that the reported event occurred due to the application of an external force, such as strong rubbing around the acoustic lens surface, during normal use, including reprocessing.The instruction manual states that an inspection of the external surface of the entire insertion section including the bending section and the distal end, should be performed.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
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