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

Catalog Number UNKNOWN

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

Patient Problem Dysphasia (2195)

Event Type  Injury  

Manufacturer Narrative

We received the attached study paper relating to the use of the duette multiband mucosectomy device.(dt-6, dt-6f¿) this study is a retrospective review of patient data to determine the efficacy of radiofrequency ablation (rfa) with or without endoscopic mucosal resection (emr) in the management of barrett's esophagus (be) with or without high grade dysplasia (hgd) or intramucosal adenocarcinoma (imc).This appears to be a us originated study circ.2014.(based on data from jan 2004 to dec 2012).The complaint was confirmed based on customer testimony.A lot number for the device was not provided therefore a review of the manufacturing and component records could not be completed.Due to the limited information provided by the customer, the fact that the device was not returned and given that the actual conditions of device usage could not be replicated, a definitive cause for the customers complaint could not be conclusively determined.However it should be noted that the instructions for use 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 unknown if this patient's pre existing condition was dysplastic barrett's oesophagus with high grade dysplasia or intramucosal adenocarcinoma as the study does not differentiate the two conditions regarding this occurrence.It is possible that the pre-existing condition of dysplastic barrett's oesophagus(with high grade dysplasia or intramucosal adenocarcinoma) 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; however this cannot be conclusively determined.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.

Event Description

As reported in the attached article: "a patient developed a symptomatic esophageal stricture requiring 3 dilations.".

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5965884
• MDR Text Key: 55205536
• Report Number: 3001845648-2016-00270
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention