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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 Blood Loss (2597)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
Procode: kns unit, electrosurgical, endoscopic.
 
Event Description
Per the 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. Postprocedural bleeding - postprocedural bleeding was diagnosed in 35 out of 3,827 mbm procedures. Of these 35 patients, 46% (16/35) used anticoagulant medication (platelet aggregation inhibitors n
=
11, vitamin k antagonist n
=
2, heparin n
=
2, factor xa inhibitors n
=
1). 16 patients, bleeding occurred within 48 hours after er, in 17 patients
=
48 hours. Patients were hospitalized for a median of 2 days (iqr 1 ¿ 3 repeat endoscopy was performed in 26 out of 35 patients, and bleeding was successfully treated using clips (n
=
9), coagulation therapy (n
=
9), or adrenalin injection (n
=
2). In 6 patients, no active bleeding was observed during re-endoscopy. Eleven patients received a median of 1 blood unit (iqr 1 ¿ 3). Seven patients were hospitalized solely for observation, without the need for intervention or transfusion (s
=
3 as per mhl). All patients fully recovered. The data from this paper was obtained from 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 NameDUETTE MULTI-BAND MUCOSECTOMY DEVICE
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key10076650
MDR Text Key193021959
Report Number3005580113-2020-00362
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
Type of Report Initial
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/23/2020
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2020 Patient Sequence Number: 1
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