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 Dysphasia (2195)

Event Date 11/26/2020

Event Type  Injury  

Event Description

Ali 2021, duette, management of esophageal strictures after endoscopic resection for early neoplasia. Esophageal emrs were performed as previously described using a therapeutic gastroscope, a multiband mucosectomy device (duette® multi- band mucosectomy, cook medical, usa), without submucosal lifting, and using the forced coagulation current. Emr and esophageal dilatation were conducted under deep sedation using propofol, and monitored by an anesthesiologist and a specialized nurse. All patients were prescribed double dose esomeprazole for 3 months after endoscopic resection. Locally injected triamcinolone in the residual submucosa or oral prednisone administration following established protocols were left at the discretion of the endoscopist. Esophageal endoscopic resections were performed, among which 166 were emr developed a postoperative esophageal stricture requiring endoscopic treatment: 7/166 (4. 2%) after emr. 7 cases post-operative emr stricture requiring endoscopic treatment. The endoscopic treatment mainly relying on balloon dilations for esophageal strictures was always an outpatient procedure. No patient required surgery for esophageal stricture.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted once the investigation is concluded.

• 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: 13652614
• MDR Text Key: 291208625
• Report Number: 3001845648-2022-00112
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 11/26/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/03/2022
• 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 Treatment Data

Date Received: 03/02/2022 Patient Sequence Number: 1