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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dysphasia (2195)
Event Date 11/26/2020
Event Type  Injury  
Event Description
Ali 2021, duette, management of esophageal strictures after endoscopic resection for early neoplasia. Esophageal emrs were performed as previously described using a therapeutic gastroscope, a multiband mucosectomy device (duette® multi- band mucosectomy, cook medical, usa), without submucosal lifting, and using the forced coagulation current. Emr and esophageal dilatation were conducted under deep sedation using propofol, and monitored by an anesthesiologist and a specialized nurse. All patients were prescribed double dose esomeprazole for 3 months after endoscopic resection. Locally injected triamcinolone in the residual submucosa or oral prednisone administration following established protocols were left at the discretion of the endoscopist. Esophageal endoscopic resections were performed, among which 166 were emr developed a postoperative esophageal stricture requiring endoscopic treatment: 7/166 (4. 2%) after emr. 7 cases post-operative emr stricture requiring endoscopic treatment. The endoscopic treatment mainly relying on balloon dilations for esophageal strictures was always an outpatient procedure. No patient required surgery for esophageal stricture.
 
Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted once the investigation is concluded.
 
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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 Key13652614
MDR Text Key291208625
Report Number3001845648-2022-00112
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
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
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/26/2020
Event Location Hospital
Date Manufacturer Received02/03/2022
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: 03/02/2022 Patient Sequence Number: 1
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