The device was returned to olympus for evaluation.The evaluation confirmed the user report.There was no ultrasonic propagation fluid in the sheath of the product.The probe body (sheath) was twisted at the probe connector (insertion point).The review of the device history record (dhr) did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The following statements are included in the instructions for use (ifu): "when using the ultrasonic probe during bronchoscopy, never use sterile, de-aerated water immersion method and balloon method.This could result in patient injury." "freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasonic energy is emitted into the patient." "never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it." "do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation." the root cause could not be established.Probable causes for "no ultrasonic propagation fluid in sheath" include fluid leak due to the damaged sheath or volatilization of the ultrasonic propagation fluid.The damaged sheath may have been caused by excessive external force or impact.Volatilization may also be cause by external impact or storage environment, it has been 14 years and 10 months since product manufacture.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.Actions are being taken to manage the actions related to remediation of this issue and any required mdr reporting.
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