MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Catalog Number DT-6-XL

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

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

Kns unit, electrosurgical, endoscopic.

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.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9917228
• MDR Text Key: 188825764
• Report Number: 3005580113-2020-00344
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DT-6-XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2020
• Distributor Facility Aware Date: 03/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• 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