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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 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.
 
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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 Key9909730
MDR Text Key196738845
Report Number3001845648-2020-00179
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
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 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
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 Date11/16/2010
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: 04/01/2020 Patient Sequence Number: 1
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