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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 Chest Pain (1776)
Event Date 02/23/2010
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions. User facility : department of gastroenterology and hepatology, westmead hospital , sydney, new south wales , australia, department of gastroenterology, princess alexandra hospital , brisbane, queensland , australia contact person : michaelj. Bourke, mbbs, fracp , director of gastrointestinal endoscopy , westmead hospital, c/- suite 106a, 151-155 hawkesbury rd , westmead , nsw 2145 , australia. E-mail: michael@citywestgastro. Com. Au.
 
Event Description
Moss-"endoscopic resection for barrett ¿ s high-grade dysplasia and early esophageal adenocarcinoma: an essential staging procedure with long-term therapeutic benefit. " two patients required narcotic analgesia for postprocedural chest pain, with same-day discharge and full recovery.
 
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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
heather ryan
o halloran road
national technology park
limerick 
MDR Report Key9915010
MDR Text Key189592031
Report Number3001845648-2020-00193
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K050578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/23/2010
Event Location Hospital
Date Manufacturer Received03/23/2020
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: 04/02/2020 Patient Sequence Number: 1
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