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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Monino et al 2019 ¿anti-reflux mucosectomy with band ligation in the treatment of refractory gastroesophageal reflux disease¿.Case of a (b)(6) man with a long history of gerd uncontrolled by proton pump inhibitor (ppi) therapy.His main symptom was daily pyrosis.Arms-b was performed in this patient in an ambulatory setting.For the arms-b procedure, a duette band ligation device (cook medical, bloomington, indiana, usa) was mounted onto an endoscope with large operating channel (3.8mm).Adrenaline serum (1/1000) was injected into the submucosa at the egj oriented toward the lesser curvature of the stomach.The mucosa was captured with the band ligation device, and piecemeal mucosectomy of three-quarters of the circumference of the egj was performed using a hexagonal snare.This potentially occurred in france or belgium, complaints were created to capture both country.This file will capture the off-label use used for the arms procedure.There was no perioperative complication.

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 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.¿anti-reflux mucosectomy with band ligation in the treatment of refractory gastroesophageal reflux disease".This file covers the off label for arms use of the duette multi-band mucosectomy device in belgium.(rpn unknown) document review: 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.¿ there was 1 patient involved in this study and according to the information received duette multi-band mucosectomy device was used to treat gerd.This is regarded as off label use as the device was used in arms procedure.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, the patient did not experience any adverse effects due to this occurrence.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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12710791
• MDR Text Key: 283976759
• Report Number: 3001845648-2021-00750
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• 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: 04/30/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2021
• 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 Sex: Male