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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 DT-6-5F
Device Problems Failure to Conduct (1114); Operating System Becomes Nonfunctional (2996)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
Per rep, on (b)(6) 2020, the snare got caught under the band while trying to do the resection. They thought that the issue was a malfunction of the cautery system that allowed the snare to get caught in the mucosa. They resolved the issue by cutting the handle of the snare after, which they used another non-cook snare that they attached over the cook snare. They put the loop of the non-cook snare over the wire of the cook snare, threaded down, and they were able to snare the pseudo polyp over the band after which the cook snare got released/dislodged. That resolved the issue. Per rep, on (b)(6) 2020, they used an olympus snare and went back to the band and snare which was stuck within the pseudo- polyp and had a similar issue so they decided to switch to an erbe generator to finish the job as they had question marks regarding the conmed generator that was being used. With another olympus snare and the erbe generator they were able to snare the pseudo polyp above the duette and dislodge the band and the cook snare. Case was resolve without any consequence to the patient. The physician who performed the case is dr anne sophie laliberte ( thoracic surgeon).
 
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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 Key10532283
MDR Text Key207034532
Report Number3001845648-2020-00609
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K050578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberDT-6-5F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/13/2020
Event Location Hospital
Date Manufacturer Received08/18/2020
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

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