The probe was returned stuck inside the transducer.Upon receipt the probe was observed to be damaged.The model and lot number of the probe were not recorded.Therefore, there is no record of an evaluation being performed.At the customer¿s request, the device was returned to the customer unrepaired.An investigation is ongoing to obtain additional information regarding this event.
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Upon further review by the legal manufacture at the time of device evaluation, it was observed that the device is not manufactured by olympus and does not need to be reported by olympus.The manufacturer of the device could not be determined from the device part that was returned.No information was received from the customer when due diligence was executed.Please see the updates in sections: g3, g6, h2, and h10.
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