• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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. [alvarez herrero - safety and efficacy of multiband mucosectomy in 1060. Pdf].
 
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) medical center, (b)(6), or the (b)(6) hospital, (b)(6). Device: duette (dt-x). Complaint details: clinically insignificant bleeding obscuring the endoscopic view and therefore requiring endoscopic hemostasis during the mbm procedure was seen during 49/243 procedures (20% [95 %cl 15% - 25 %]). Hemostasis was achieved by focal coagulation of the bleeding vessel with the tip of the snare (32 procedures), apc (3), electrosurgical hemostatic forceps (1), clip (7), adrenaline (1), or a combination of these therapies (5). These bleedings were not considered to be acute complications but were regarded as events intrinsic to the resection, since the management of the patient did not alter: none of the bleedings resulted in hospital admission, blood transfusion, or repeat endoscopic intervention,and all of these patients were discharged after the normal postprocedural observation period of 2 -4 hours.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9909558
MDR Text Key196902895
Report Number3001845648-2020-00178
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 Other Health Care Professional
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
-
-