MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Serrero, 2020, duette, cuffitis: is an endoscopic approach possible? for the third patient, a circular mucosectomy was performed with the duette system (cook medical) using six elastic bands after detachment with an adrenaline-saline solution.Perioperative controls revealed circular resection over 1 cm.The pathological analysis was compatible with lesions of uc without dysplasia.Slight bleeding occurred in the immediate postoperative period.As a result, the patient was discharged on the day after the procedure.One month later, the patient has not experienced further symptoms or rectal bleeding.This complaint is capturing 1 case of slight bleeding in patient #3, as per input received from the medical advisor, the bleeding was related to duette device.However, it was off-label use in lower gi.Patient outcome: one month later, the patient has not experienced further symptoms or rectal bleeding.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation the duette multi-band mucosectomy device of lot number unknown involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4) (reporting reference number 3001845648-2021-00294) - serrero - ¿patient #2: occasional anal bleeding¿ as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all duette multi-band mucosectomy device are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0026-10) states the following: ¿this device is for endoscopic mucosal resection in the upper gi tract.¿.There is evidence to suggest the user did not follow the ifu.A definitive root cause can be attributed to off label use.When the device is used outside of its validated state it is not possible to definitively state how the device will perform.As per ifu, the duette is for use in the upper gi tract, not for lower gi tract which was treated in this article.Therefore, the duette was off-label use in this study.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient suffered from slight bleeding.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS 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 Key: 11639882
• MDR Text Key: 261740444
• Report Number: 3001845648-2021-00295
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2021
• 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 Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female