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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 Off-Label Use (1494)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 07/16/2020
Event Type  malfunction  
Event Description
Debourdeau et al 2020 (duette) ¿ ¿antireflux mucosectomy band (arm-b) in treatment of refractory gastroesophageal reflux disease after bariatric surgery¿. Arm-b procedures were performed under general anesthesia with tracheal intubation. Patients were placed in a supine posi-tion. A large operating channel endoscope (3. 8 mm) was used for the procedure (fujinon, tokyo, japan or pentax, tokyo, japan), with a multi-band ligation device (duette, cook medical, winston salem, usa) placed at the tip of an endo-scope. The endoscope was positioned at the level of egj within the axis of the lesser curve. Then, the procedure was as follows: a 23-g needle was used to inject in the submucosa adren-aline serum (1/1000) for mucosal lifting. The egj mucosa was captured with band ligation (1 cm in the esophagus and 2 cm in the stomach). The captured mucosa was cut with a hexagonal snare (duette, cook medical, winston salem, nc, usa). The electrosurgical unit setting was endocut q, effect 2 (erbe, erlangen, germany). These three steps were repeated until completion of a piece-meal mucosectomy of three-quarters of the circumference, involving predominantly the gastric side of the eg junction. One patient had upper gi bleeding with 2 g/dl of hemoglobin loss managed conservatively with iron perfusion and ppis. This file will capture the potential that this event occurred in belgium, pr 327094 will capture the potential that this event occurred in france. Off label use confirmed on 01-oct-21 - used for arms procedure. One patient had upper gi bleeding with 2 g/dl of hemoglobin loss managed conservatively with iron perfusion and ppis.
 
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
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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
aisling hassett
o halloran road
national technology park
limerick 
MDR Report Key12710929
MDR Text Key284458930
Report Number3001845648-2021-00749
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K050578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
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? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/16/2020
Event Location Hospital
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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