This pr was opened to address the following; "6 patients developed strictures while undergoing emr which required dilations".The devices were not returned to cirl for evaluation therefore a documentation based investigation was completed.The complaint was confirmed based on customer testimony.Lot numbers for the devices were not provided therefore a review of the manufacturing and component records could not be completed.A definitive cause for the customers complaint could not be conclusively determined as the actual conditions of device usage could not be replicated.However the instructions for use ifu0026-8 states the following warning regarding potential complications which includes stricture formation ; " potential complications associated with emr include, but are not limited to: retrosternal pain, nausea, laryngeal laceration, oesophageal perforation, stricture formation, obstruction, haemorrhage." it is also possible that the pre-existing condition of dysplastic barrett's esophagus may have contributed to the stricture formation however this cannot be conclusively determined as a contributing factor.The most probable root cause of this event is operational context as stricture formation is listed as a known complication of emr.Prior to distribution all duette devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook (b)(4).Complaints of this nature will continue to be monitored for potential emerging trends.
|