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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE
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COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Stenosis (2263)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
Procode: kns unit, electrosurgical, endoscopic.
 
Event Description
Per journal article: risk factors for serious adverse events associated with multiband mucosectomy in barrett¿s esophagus: an international multicenter analysis of 3827 endoscopic resection procedures.Belghazi et al.2020.Stenosis - stenosis requiring endoscopic treatment was observed in 231 out of 2447 patients accounting for a stenosis rate of 9.4 %.In 219 out of 231 patients, median 2 (iqr 1 ¿ 4) dilations were required.The remaining patients underwent incision therapy (n=2).The remaining patients underwent stent placement (n=10).The data from this paper was obtained from 7 countries 7 countries ((b)(6), united states) as an exact location cannot be determine for the complaints, a complaint has been originated for each location.
 
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Brand Name
DUETTE MULTI-BAND MUCOSECTOMY DEVICE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10078601
MDR Text Key193023333
Report Number3005580113-2020-00364
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/20/2020,05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/23/2020
Event Location Hospital
Date Report to Manufacturer05/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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