Customer entity: (b)(6) medical center, amsterdam, or the (b)(6) hospital, nieuwegein, the netherlands.Device evaluation the duette devices of unknown lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article."alvarez herrero-safety and efficacy of multiband mucosectomy in1060 resections in barrett's esophagus." multiple complaint files were opened as a result of this paper.This file was opened to investigate the early complications consisted of 5/243 delayed bleedings (2.1 % [95 %cl 0.7% - 4.7 %]), 4 of these occurring within 48 hours and 1 after 6 days.All delayed bleedings were effectively managed endoscopically and graded as 'moderate' as a repeat endoscopy was required in all cases and blood transfusion with less than 4 units in 3 cases.No association was found between delayed bleeding and the number of specimens resected.Document review: as the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution dt-6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the duette devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.It should be noted that the instructions for use ( ifu0026-10)which informs the user about the potential complications "those associated with emr include, but are not limited to : retrosternal pain, nausea, laryngeal laceration, esophageal perforation, stricture formation, obstruction, haemorrhage." there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.Medical advisory has confirmed that the device functionality did not contribute to the issue.This effects experience were the result of the procedure being performed.Summary: complaint is confirmed based on customer testimony.All delayed bleedings were effectively managed endoscopically and graded as 'moderate' as a repeat endoscopy was required in all cases and blood transfusion with less than 4 units in 3 cases.Complaints of this nature will continue to be monitored for potential emerging trends.- attachment: [alvarez herrero - safety and efficacy of multiband mucosectomy in 1060.Pdf].
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