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 03/25/2011

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: randomized trial on endoscopic resection-cap versus multiband mucosectomy for piecemeal endoscopic resection of early barrett¿s neoplasia doi:10. 1016/j. Gie. 2011. 03. 1243. Origin: netherlands. Date aware: 04-mar-2020. Study details: to compare er-cap and mbm for piecemeal er of early barrett¿s neoplasia. This study involved 84 patients (64 men; median age 70 years) undergoing piecemeal er of barrett¿s neoplasia. Rpn: duette multi-band mucosectomy kit cook medical, limerick, ireland). All er procedures were performed at the academic medical center amsterdam, st. Antonius hospital nieuwegein, catharina hospital eindhoven, or the university hospitals leuven. Date of event: jan 2005-june 2010. Complaint details: minor bleeding during the er procedure occurred n 17 patients (40%) treated with mbm. None of these bleeding episodes were considered clinically relevant because all could be treated endoscopically during the same procedure by using conventional hemostatic techniques such as adrenalin injection, hemoclips, coagulation with the tip of a snare, apc, hot biopsy forceps, or a combination thereof. No delayed bleeding was reported.

• 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: 9915000
• MDR Text Key: 189592306
• Report Number: 3001845648-2020-00182
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/22/2020

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?: 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: 03/25/2011
• 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: 04/02/2020 Patient Sequence Number: 1