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 Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 11/16/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Study title: safety and efficacy of multiband mucosectomy in 1060 resections in barrett's esophagus. Http://dx. Doi. Org/10. 1055/5-0030-1256095. Origin: (b)(6). Date aware: 04-mar-2020. Customer entity: (b)(6). Device: duette (dt-x). Complaint details: clinically significant bleeding occurred in 7/243 procedures (3% [95 %ci 1 %-6%]). Hemostasis was achieved with standard endoscopic therapy during the procedure (tip of the snare in 4; clip in 1; clip and adrenaline in 1; apc and adrenaline 1). Six bleedings were graded as a 'mild' complication as these patients had an unplanned hospital admission and were discharged after 1- 2 days of observation. One bleeding was graded as a 'moderate' complication as the patient underwent elective endoscopic re-inspection without additional intervention. None of the patients with a clinically significant bleeding during the mbm procedure developed a recurrent bleeding. Clinically significant bleeding was associated with a higher number of resections per procedure (p
=
0. 02) with an odds ratio of 1. 19 (95 %cl 1. 02 -1. 40) per resection.

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick
• MDR Report Key: 9909730
• MDR Text Key: 196738845
• Report Number: 3001845648-2020-00179
• 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: health professional,literatur

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2010
• Event Location: Hospital
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/01/2020 Patient Sequence Number: 1