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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis of the esophagus (4487)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

White 2021, endoscopic management of barrett¿s dysplasia and early neoplasia: efficacy, safety and long-term outcomes in a uk tertiary centre.The borders of lesions were marked by electrocautery snare.Resection was achieved by two methods.The first method using the mbm technique (duette; cook endoscopy, limerick, ireland/captivator device (boston scientific ltd): a pseudo polyp is created by suction then resected after deployment of a rubber band.This is then resected with a hot snare.This process is repeated until the lesion is completely resected.Delayed complications of symptomatic strictures were 2.5% requiring a median of 1 dilatation.Required secondary intervention.Patient info: mean age 67 years, male:female ratio 183:38.

Manufacturer Narrative

Device evaluation: the duette device of lot number unknown involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all duette devices 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-) states the following: ¿contraindications specific to esophageal banding include, but are not limited to: cricopharyngeal or esophageal narrowing or stricture, tortuous esophagus, esophageal varices, diverticula ¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause can be attributed to a procedural related effect as per the instructions for use (ifu0026-10) stricture formation is a known complication associated with the use of the device.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required additional surgery due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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

• 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: 13692253
• MDR Text Key: 291509453
• Report Number: 3001845648-2022-00118
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/28/2022

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?: No
• 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: 01/31/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 05/26/2022
• 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: 67 YR
• Patient Sex: Male