MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number DT-6-XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The rate of symptomatic strictures after emr was low at 1.0% per patient (7 cases).None of the cases had used intervening pdt and all strictures occurred with emr only.All stricture cases were successfully treated with endoscopic dilation (12 balloon dilations and 2 savary dilations in total).On average, two dilations were needed to obtain long-lasting relief from strictures.

Event Description

The investigation was concluded on the (b)(6) 2020, this supplement report is being submitted to include the investigation conclusions.

Manufacturer Narrative

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 "tomizawa - safety of endoscopic mucosal resection for barrett¿s esophagus" multiple complaint files were opened as a result of this paper.This file pr was opened to investigate 7 cases of symptomatic strictures after emr.Lab evaluation ¿ n/a.Image review ¿ n/a.Document review as the lot number of the complaint duette devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution duette 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.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, oesophageal 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 advisor has confirmed that the device functionality did not contribute to the issue.This effects experience were the result of the procedure being performed."the strictures were likely due to the resection procedure and patient's underlying condition.The complaint was device related as cook device was involved in the procedure, but these complaints were not related to device functionality and device was performed as its intended use." summary: complaint is confirmed based on customer testimony.None of the (b)(4) cases had used intervening pdt and all strictures occurred with emr only.All stricture cases were successfully treated with endoscopic dilation (12 balloon dilations and 2 savary dilations in total).On average, two dilations were needed to obtain long-lasting relief from strictures.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9910244
• MDR Text Key: 189591463
• Report Number: 3001845648-2020-00184
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DT-6-XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention