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 Problem Stenosis of the esophagus (4487)

Event Date 07/16/2020

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

Debourdeau et al 2020 (duette) ¿ ¿antireflux mucosectomy band (arm-b) in treatment of refractory gastroesophageal reflux disease after bariatric surgery¿.Arm-b procedures were performed under general anesthesia with tracheal intubation.Patients were placed in a supine posi-tion.A large operating channel endoscope (3.8 mm) was used for the procedure (fujinon, tokyo, japan or pentax, tokyo, japan), with a multi-band ligation device (duette, cook medical, winston salem, usa) placed at the tip of an endo-scope.The endoscope was positioned at the level of egj within the axis of the lesser curve.Then, the procedure was as follows: a 23-g needle was used to inject in the submucosa adren-aline serum (1/1000) for mucosal lifting.The egj mucosa was captured with band ligation (1 cm in the esophagus and 2 cm in the stomach).The captured mucosa was cut with a hexagonal snare (duette, cook medical, winston salem, nc, usa).The electrosurgical unit setting was endocut q, effect 2 (erbe, erlangen, germany).These three steps were repeated until completion of a piece-meal mucosectomy of three-quarters of the circumference, involving predominantly the gastric side of the eg junction.One patient had an esophageal stricture treated endoscopically by one single dilation session (hydraulic balloon, inflated at 13.5 mm) 2 weeks later.This file will capture the potential that this event occurred in france, pr 327095 will capture the potential that this event occurred in belgium.One patient had an esophageal stricture treated endoscopically by one single dilation session (hydraulic balloon, inflated at 13.5 mm) 2 weeks later.

Manufacturer Narrative

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

Event Description

Supplemental report: off label use confirmed on 01-oct-21 - used for arms procedure.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: the duette devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation ¿ n/a.Documents review including ifu review: as the rpn and lot number is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution dt devices 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.¿ 6 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.Image review ¿ n/a root cause review 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 initial reporter, one patient had an esophageal stricture treated endoscopically by one single dilation session (hydraulic balloon, inflated at 13.5 mm) 2 weeks later.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: 11628364
• MDR Text Key: 261000716
• Report Number: 3001845648-2021-00270
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/07/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 03/09/2021
• Supplement Dates FDA Received: 10/28/2021; 11/24/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female