The subject device was returned to (b)(4), however the subject device was not returned to olympus medical systems corp.(omsc) for evaluation yet.The subject device is now in transit from (b)(4) to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Olympus was informed that four patients suffered injury during colonoscopies using with same ucr.In all four cases, the water was poured for cleaning of the patient¿s mucosa and co2 was insufflated into the patient with the ucr, then the patient¿s mucosa turned white and raised.Furthermore, in one of the four cases, the patient suffered rectal bleeding and was transported to the emergency room, however the medical intervention was not necessary.In another one of the four cases, the patient had abdominal pain for four days.All four patients recovered and became well.This report is 2 of 4, which is regarding the abdominal pain and the injury of the mucosa.
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The subject ucr was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the inside and exterior of the subject ucr visually, there was no abnormality and irregularity.Omsc confirmed the flow rate and the supply pressure of insufflation of the subject ucr and found that the flow rate and the supply pressure were within the specification.Furthermore, the subject ucr operated without any problem.Omsc checked the device history record of the subject ucr there was no irregularity found.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility that this phenomenon was attributed to the cause except the subject ucr.Olympus stated the appropriate handling of ucr and the counter measures against abnormalities in the instruction manual of ucr.
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