Brush stuck in the op-channel.This event occurred at the time of during reprocessing.There was no report of patient harm.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
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Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d4:unique identifier (udi) h4:device manufacture date evaluation summary based on the content of investigated data, it was determined that the potential cause/root cause of failure was that an incompatible disc-shaped brush with folds was used during reprocessing, resulting in the product getting stuck in the pipeline.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 26-mar-2012 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 27-mar-2012.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
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