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

Model Number	G34054
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Device evaluation: the dt-6-xl device of lot involved in this complaint was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: 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.Review historical data: not applicable for use error complaints as per d00059858 rev 032 - table 1 - investigation requirements.Instructions for use/label.The notes section of the instructions for use (ifu0026), which accompanies this device instructs the user to "insert the multi-band ligator handle into the endoscope accessory channel following the instructions below for the appropriate endoscope.Olympus-see fig.3a, pentax -see fig.3b, fujinon-see fig.3c".There is evidence to suggest that the customer did not follow the instructions for use, as incorrect size of endoscope was used.As per additional information provided "our warehouse manager mistakenly ordered the xl size instead of the standard size, so understandably there have been issues using the product with a standard gastroscope.This was therefore an error on our part that we had not previously noticed.The product has functioned flawlessly.So the statement referred to the endoscope." image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause was established.The user has not complied with the requirements of the ifu and/label.It may be noted incorrect size of endoscope was used, likely causing issue reported -the product sling would not pass through the endoscope's working channel.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary: according to the additional information received, the product sling would not pass through the endoscope's working channel.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu and/label.It may be noted incorrect size of endoscope was used, likely causing issue reported -the product sling would not pass through the endoscope's working channel.Use error complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required.
Event or Problem Description
It was noted at the start of the procedure that the product sling would not pass through the endoscope's working channel.The duration of the procedure was prolonged due to the faulty product.

• 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: 25067421
• Report Number: 3001845648-2026-00165
• Device Sequence Number: 18812923
• Product Code: KNS
• UDI-Device Identifier: 00827002340541
• UDI-Public: (01)00827002340541(17)261217(10)C2387897
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Report Date (Section B): 04/16/2026

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 Model Number: G34054
• Device Catalogue Number: DT-6-XL
• Device Lot Number: C2387897
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2026
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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