The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center found, the control body name plate missing, switch/camera button cut, elevator channel inlet loose, suction flow cylinder worn, insertion tub has minor dent, customer label blocking olympus caution label and the bending section cover cracked.The faulty parts were replaced.The device was inspected and passed olympus functional standards.A definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, in regards to the adhesive peeling at the distal end and the probe unit being cut, multiple damages were confirmed at the distal end, so it is possible that an external force was applied to the distal end.A definitive root cause could not be identified.A description concerning distal end is stated in the instruction manual at the time of the shipping.Per the instruction manual: "do not apply shock to the distal end of the insertion section, particularly the ultrasound transducer and the objective lens surface at the distal end.Visual abnormalities may result." olympus will continue to monitor field performance for this device.
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