The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past one year from the incident date,it was found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that the needle could not be extended out from the sheath since the frictional resistance became higher between the outer tube and the inner tube due to the kinked outer tube.The instruction manual of the device has already warned as follows; *when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.*always have a spare instrument available in case the primary instrument malfunctions.
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When the user was performing polypectomy during a colonoscopy, two nm-400u-0423 devices were used.In the procedure, the needle of the two devices could not be extended out from the sheath.Therefore, the user discontinued the procedure.There was no patient injury reported.The intended procedure was performed in another day and completed without any problem.This is the report regarding the first of the two devices.
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