MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G34036
Medical Device Problem Codes	Break (1069); Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
When using the emr kit below, both blue tips came out of the white device that it sued to thread the duetter through the scope.Ref g34036 lot # c2301730"."we did open another one and it was not like this when opened, but hese fell out when trying to load the device in the scope.Not used on patient.".
Event or Problem Description
A supplemental report is being submitted due to receipt of additional information on 26 aug 2025 and 16 oct 2025, along with completion of the investigation on 20 oct 2025.The following additional information was received on 26 aug 2025 via email.1.Is an acknowledgment letter (formal notification of the complaint being received) required? no 2.Is any account action needed (credit, no charge replacement, no action, investigation results, etc.)? 3.What was the date of the occurrence? (b)(6) 2025 4.Are images available as per the source email there is an image mentioned but there is non-present.No 5.Will the facility be reporting this to a government agency (fda, competent authority, etc.) no 6.Is the device available for return? yes 7.What was the intended procedure? emr 8.Could it be confirmed how many devices are being reported with issues in this complaint? we now have 2 9.Please advise the anatomical location of the intended target site not used in patient 10.What make & model of endoscope was used? not sure- fuji 11.Was lubricant allowed between the inside of the ligator and the endoscope's distal end? n/a, yes, no not sure 12.Was the endoscope curved or straight during loading of the trigger cord into the handle? n/a, curved, straight do not remember.Additional information received via email on 16 oct 2025.When using the emr kit below, both blue tips came out of the white device that it sued to thread the duetter through the scope.Ref g34036 lot # c2301730.
Additional Manufacturer Narrative
Device evaluation the dt-6 device of lot number c2301730 involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.This complaint is related to the following complaints: (b)(4) - blue hooks are falling out of the white cord used to pull the device snug to the scope.(b)(4) - device returned with blue hook detached from loading catheter.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label review: it should be noted that the instructions for use (ifu0026) states the following: ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to joints, cracks or breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ ¿attach the trigger cord to the hook on the end of the loading catheter, leaving approximately 2cm of trigger cord between the knot and the hook (fig.5).Withdraw the loading catheter and trigger cord up through the endoscope and out through the multi-band ligator handle.¿ ¿introduce the loading catheter through the white seal in the multi-band ligator handle and advance, in short increments, until it exits the tip of the endoscope¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined.A possible root cause could be attributed to device handling.It is possible that increased pressure or force while attaching the trigger cord to the hook led to the hooks becoming loose and subsequently led to the hooks detaching from the loading catheter while advancing through the scope.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01 x prior to use device.Corrective action/correction complaints of this nature will continue to be monitored for similar events.Summary of investigation according to the initial reporter, the device did not make patient contact.No adverse effects were reported as a result of this occurrence.Investigation findings conclude that a possible root cause could be attributed to device handling.The complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for similar events.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Common Device Name: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22812801
• Report Number: 3001845648-2025-00399
• Device Sequence Number: 8703493
• Product Code: KNS
• UDI-Device Identifier: 00827002340367
• UDI-Public: (01)00827002340367(17)260506(10)C2301730
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K050578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2026
• Device Model Number: G34036
• Device Catalogue Number: DT-6
• Device Lot Number: C2301730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown