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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Dysphasia (2195)

Event Date 01/22/2020

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

Monino et al 2020 ¿antireflux mucosectomy band in treatment of refractory gastroesophageal reflux disease: a pilot study for safety,feasibility and symptom control¿.This was a pilot study with consecutive cases conducted in marseille between june 2017 and january 2019.Then a multi-band ligation device ((b)(4), cook medical, (b)(4), usa) was fitted on the endoscope.The endoscope was positioned at the level of egj towards the axis of the lesser curve.Then the procedure was as follows: a 23-g needle was used to inject in the submucosa adrenaline serum (1/1000) for mucosal lifting.The egj mucosa was captured with band ligation (1 centimetre in the esophagus and 2 cm in the stomach).The captured mucosa was cut with a hexagonal snare ((b)(4), cook medical, (b)(4), united states).The electrosurgical unit setting was endocut q, effect 2 (b)(4).21 patients ¿ 11 men and 10 women ¿ mean age 56.8 ± 14.4 years were included in the study.Three patients suffered from dysphagia that occurred at 2 to 4 weeks.They were managed by endoscopic hydraulic dilatation (12-mm caliber) requiring one session in one case and two sessions in the two other cases.This potentially occurred in (b)(6), complaints were created to capture both countries.They were managed by endoscopic hydraulic dilatation.

Event Description

Supplemental report is being submitted due to the confirmation received that the device was used off label and completion of the investigation.

Manufacturer Narrative

Device evaluation: the duette multi-band mucosectomy device of unknown lot number and rpn involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the journal article.¿antireflux mucosectomy band in treatment of refractory gastroesophageal reflux disease: a pilot study for safety, feasibility and symptom control" this file pr 327348 (report reference number 3001845648-2021-00269) covers the occurrence of off label for arms use of the duette multi-band mucosectomy device in france and the adverse effect of dysphagia.(rpn unknown).As the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all duette multi-band mucosectomy device are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use possible for this device, ifu0026-10 which would accompany this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ it should be noted that the device was used off-label, outside its intended use stated in the instructions for use ifu0026-10 ¿for endoscopic mucosal resection in the upper gi tract¿ "do not use this device for any purpose other than stated intended use.¿ 21 patients were involved in this study and according to the information received duette multi-band mucosectomy device was used throughout the study to treat gerd.This is regarded as off label use as the device was used in arms procedure.A definitive root cause can be attributed to the off-label use of the device, when the device is outside its stated intended use it may lead to outcomes that were never intended to happen and were never studied.Where the arms procedure use of the device is not a stated use as per the ifu and therefore has not being tested in a clinical setting.Summary: complaint is confirmed based on customer testimony.According to the information reported, 3 patients suffered dysphagia that occurred at 2 to 4 weeks.Managed by endoscopic hydraulic dilatation (12mm caliber) requiring one session in one case and two sessions in the two other cases.Complaints of this nature will continue to be monitored for potential emerging trends.Please note the closure date was revised due to the plm notification regarding the off label use.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11628375
• MDR Text Key: 261313547
• Report Number: 3001845648-2021-00269
• 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
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR