Olympus was informed that during colonoscopy, when the physician inserted the colonoscope, though the subject device attached to the scope was not being operated, the patient's sigmoid colon swelled.The facility was aware that the subject device was improperly attached to the colonoscope.Olympus was informed that the patient complained about pain when a sigmoid colon swelled, however there was no patient injury reported.
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Four pieces of maj-2010 including the subject device used in the user facility were returned to manufacturer for evaluation.As the result of the evaluation, it was revealed that there were no damage of deformation observed with all four units, and that there was no irregularity found.One of the returned devices were attached to a colonoscope of the same model as used in the reported event to test aspiration of co2 gas.As the result, it was confirmed that the reported phenomenon reproduced when the subject device was improperly attached.Based on the above, it could not be ruled out as a contributory factor to the event, that the subject device was improperly attached to the colonoscope.
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