The referenced device was returned to the service center for evaluation.The reported issue was confirmed; the tip of the probe was damaged with its protective cover detached.The device is non-serviceable and was returned to the customer.The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time.However, if additional information becomes available a follow up medical device 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 less than 1 year, since the subject device was manufactured.Based on the results of the investigation, it is likely, that the tip sheath was stretched and broken.Resulting in dislodgement, due to excessive external forces applied to the tip sheath when attempting to remove the stopper.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "instructions single use guide sheath kit k-401, k-402 9 operation, 9.2 inspection.Inspection of operation: attachment of the us stopper caution.¿ review the instruction manual of the ultrasonic probe for the inspection and operation of the ultrasonic probe.¿ when attaching the us stopper to the ultrasonic probe, avoid contact with the insertion portion of the ultrasonic probe with your bare hands.Any grease on the insertion portion may compromise the functions of the us stopper.¿ when attaching the us stopper to the ultrasonic probe, do not force the ultrasonic probe.This may cause damage to the instrument and/or the ultrasonic probe.¿ when moving the us stopper on the insertion portion of the ultrasonic probe, do not grasp it with an excessive force, so as not to close the slit.If the us stopper is moved while the slit is closed, the ultrasonic probe may be damaged.When you use the guide sheath in combination with the ultrasonic probe, attach it as instructed below".Olympus will continue to monitor the field performance of this device.
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