This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: based on the 3-digit lot number provided, the manufacturing date of the device was in the month of june 2021 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was not returned for evaluation.Based on the results of the investigation, the root cause of this event (balloon would not deflate) was unable to be identified.The following is included in the instructions for use: ¿before use, prepare and inspect the instrument as instructed below.Should any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection-control risk, cause tissue irritation, perforation, bleeding, or mucous membrane damage and may result in more severe equipment damage.Inflate the balloon only with air.Inflation with anything other than air may hinder expansion and contraction of the balloon.If it is difficult to pull the plunger of the premeasured syringe when deflating the balloon, detach the premeasured syringe from the air-feeding port.If resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal of the instrument could damage the instrument and/or endoscope.When using an endoscope equipped with a forceps elevator, do not withdraw the instrument from the endoscope if the forceps elevator is up.This could damage the instrument.¿.Olympus will continue to monitor field performance for this device.
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