This is a supplemental report to provide additional information.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.Omsc checked the evaluation result by olympus beijing sales & service co., ltd.And confirmed that the liquid could hardly be injected through the needle.It was also confirmed that the sheath was not buckled or clogged with foreign materials.The manufacturing record was reviewed and found no irregularities.Based on the result of manufacturing record review and evaluation result by olympus beijing sales & service co., ltd., omsc presumes that the event occurred since something was clogged in the needle.The above device handling has warned in the instruction manual as follows.Before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example:posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage.Inspecting injection: 1.Push the slider into the holder portion until it clicks into position to extend the needle from the distal end of the tube.2.Inject a fluid intended for patient use into the instrument¿s injection port using a sterile syringe.Confirm that the fluid comes out of the distal end of the needle.3.Make sure that the fluid is not discharged from any areas other than the distal end of the needle.
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