A user facility submitted a repair request to the olympus service center, for an evis lucera elite gastrointestinal videoscope, having poor air and water supply.Upon inspection and testing of the customer returned device, foreign material was found in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.
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The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, air/water could not be supplied due to nozzle clogging, bending angle insufficient due to elongation of the angle wire, play of the angle knob out of the normal state due to elongation of the angle wire, scratches found on the operation part, scratches found on the switch box, scratches on the operation unit cover, scratches found on the grip, scratches found on the universal cord, scratches found on the operation part side oredome of the universal cord, scratches on the scope connector side of the universal cord, scratches found on the scope connector, and scratches on the scope connector cover.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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