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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 Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Dysphasia (2195)
Event Date 01/22/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Monino et al 2020 ¿antireflux mucosectomy band in treatment of refractory gastroesophageal reflux disease: a pilot study for safety,feasibility and symptom control¿. This was a pilot study with consecutive cases conducted in marseille between june 2017 and january 2019. Then a multi-band ligation device ((b)(4), cook medical, (b)(4), usa) was fitted on the endoscope. The endoscope was positioned at the level of egj towards the axis of the lesser curve. Then the procedure was as follows: a 23-g needle was used to inject in the submucosa adrenaline serum (1/1000) for mucosal lifting. The egj mucosa was captured with band ligation (1 centimetre in the esophagus and 2 cm in the stomach). The captured mucosa was cut with a hexagonal snare ((b)(4), cook medical, (b)(4), united states). The electrosurgical unit setting was endocut q, effect 2 (b)(4). 21 patients ¿ 11 men and 10 women ¿ mean age 56. 8 ± 14. 4 years were included in the study. Three patients suffered from dysphagia that occurred at 2 to 4 weeks. They were managed by endoscopic hydraulic dilatation (12-mm caliber) requiring one session in one case and two sessions in the two other cases. This potentially occurred in (b)(6), complaints were created to capture both countries. They were managed by endoscopic hydraulic dilatation.
 
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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 Key11628375
MDR Text Key261313547
Report Number3001845648-2021-00269
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 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
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? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/22/2020
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

Patient Treatment Data
Date Received: 04/07/2021 Patient Sequence Number: 1
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