The subject device was returned to olympus medical systems corp.(omsc) for the evaluation.Omsc found the followings: the visual inspection.There was a hole at the distal part of the sheath of the subject device.Blood was invading from its hole at the distal part.The ultrasonic propagation fluid medium was leaking from its hole at the distal part.There was an indentation on the distal part of the sheath of the subject device.The image inspection.The ultrasound image of the subject device was not drawn normally.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the evaluation, omsc surmised there was the possibility this phenomenon was attributed to occurring a hole at the distal part of the sheath of the subject device due to some external force applied to the distal part by the user handling.Some external force might be swiftly insertion/withdrawing of the subject device from the endoscope with angulation and/or driving the probe.If additional information becomes available, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed from the user that it was found the dirt on the distal end of the subject device during the unspecified diagnostic procedure with alternate using the subject device and the endoscope.The user tried to wipe the dirt, but the dirt could not be gotten off.After the procedure, the user found the blood inside the distal part of the subject device.There was no patient injury associated with this report.
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