MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE

Model Number	G35129
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: kns unit, electrosurgical, endoscopic.
Event or Problem Description
According to the initial reporter: a patient of undisclosed gender and age underwent an egd procedure in which the duette multi-band mucosectomy device, g35129, was used.This procedure was the first time the tech used this device and had the assistance of the physician loading onto the scope appropriately.As the device was advanced into the mouth the string completely broke causing all six of the bands to come off just above the patients airway.Multiple interventions, x-rays and bronchotomy, were done during the procedure to ensure no bands were in the airway or lungs.The physician was able to account for all of the bands except for one.Four bands were located in the patients mouth and throat.The fifth band was located externally of the patient.And the sixth band was not found internally or externally of the patient.No bands were located in the airway nor in the lungs during the bronchotomy.The physician as the procedure had already been disrupted stopped the procedure and did not continue at this time.No plans to reschedule were made at this time.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12217296
• Report Number: 3005580113-2021-00094
• Device Sequence Number: 19927769
• Product Code: KNS
• UDI-Device Identifier: 00827002351295
• UDI-Public: (01)00827002351295(17)210922(10)C1762190
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2021
• Report Date (Section F): 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: G35129
• Device Catalogue Number: DT-6-5F
• Device Lot Number: C1762190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention