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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)
Event Type  Injury  
Manufacturer Narrative
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
I received call from erbe rep who told me that she had been told by staff that they have been getting one to two bleeds per week when they use the duette. She has checked the erbe diathermy machine & the machine is working ok. Rep update ( 07/10/2020): cook received a call from a erbe rep who told us that she had been told by staff at (b)(6) hospital that they have been getting one to two bleeds per week when they use the duette. She has checked the erbe diathermy machine & the machine is working ok. She believes the settings on the erbe machine they were using was endocut. I and my colleges have contacted other duette end users and enquired what erbe settings they currently use and i have forwarded that information onto (b)(6) at the (b)(6) research centre. I have spoken with (b)(6) who is the senior research sister and is unable to provide me with any dates of occurrences or any lot numbers of our duette. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. ( not sure). According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. ( not sure).
 
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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 Key10722080
MDR Text Key212720104
Report Number3001845648-2020-00814
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeGB
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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
Event Location Hospital
Date Manufacturer Received09/25/2020
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: 10/22/2020 Patient Sequence Number: 1
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