The device was returned for investigation.Upon evaluation of the device, the instrument was leaking from the bending section rubber.In addition, a deep cut into the rubber probe covering was noted.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, 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 final 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 14 years since the subject device was manufactured.Based on the results of the investigation, the cause of the deep cut on the acoustic lens surface likely occurred due to an external force applied to the distal end.The specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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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