The subject device was returned to omsc for evaluation.The ultrasonic image was not depicted normally.There was a dent on the distal end sheath.There was a hole and a fuzz in the insertion part sheath.The ultrasonic probe was not damaged.The distal end sheath was cut in order to check whether there was an ultrasonic medium.As a result, no ultrasonic medium remained inside.The device was driven normally.The manufacturing record was reviewed and found no irregularities.Omsc presumed that the reported event was that the ultrasonic images could not be depicted normally.Omsc presumed that the ultrasonic waves could not be transmitted normally, and the ultrasonic images could not be depicted normally because holes occurred in the insertion part sheath and the ultrasonic medium leaked out and decreased.
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Olympus medical systems corp.(omsc) was informed by the customer that during the bronchoscopy, there was a defect, the runtime had not yet been reached.The procedure was not completed.There was no report of patient injury associated with the event.The event date was unknown.The subject device was returned to omsc for evaluation.On (b)(6) 2021, omsc found that there was a leakage of ultrasonic medium.
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