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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
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.
 
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Brand NameDUETTE MULTI-BAND MUCOSECTOMY DEVICE
Type of DeviceKNS 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 Key9915000
MDR Text Key189592306
Report Number3001845648-2020-00182
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K050578
Number of Events Reported1
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 Received04/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/25/2011
Event Location Hospital
Date Manufacturer Received03/04/2020
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
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