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 Problems Stenosis (2263); No Information (3190)

Event Date 11/27/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Study title: clinical value of multiband mucosectomy for the treatment of squamous intraepithelial neoplasia of the esophagus.Origin: (b)(6).Date aware: 04-mar-2020.Study details: total of 51 lesions located at esophagus from 43 patients were treated with mbm, among which 11 were diagnosed as middle-grade intraepithelial neoplasia, 25 as high-grade intraepithelial neoplasia, and 15 as early esophageal cancer pathologically.Primary end-points were the rate of complete endoscopic resection and the mean operation time; the second end-points were the postoperative local recurrence rate and acute plus early complications.The histopathological results were compared between pre-mbm biopsy and mbm specimens.All patients were followed up endoscopically.Rpn: duette multi-band mucosectomy kit cook medical, limerick, ireland).Recurrence after an mbm was treated by apc in two patients and by mbm in one patient.

Manufacturer Narrative

Device evaluation: the duette devices of unknown lot numbers 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 "jin-clinical value of multiband mecosectomy for the treatment of squamous intraepithelial neoplasia of the esophagus" multiple complaint files were opened as a result of this paper.This file was opened to investigate recurrence after an mbm was treated by apc in two patients and by mbm in one patient.Lab evaluation ¿ n/a.Image review ¿ n/a.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 duette 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.It should be noted that the instructions for use ( ifu0026-10)which informs the user about the potential complications "those associated with emr include, but are not limited to : retrosternal pain, nausea, laryngeal laceration, esophageal perforation, stricture formation, obstruction, haemorrhage." there is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.Medical advisory has confirmed that the device functionality did not contribute to the issue.This effects experience were the result of the procedure being performed or patient's underlying condition related.Summary: complaint is confirmed based on customer testimony.Two patients experienced a recurrence after an mbm were treated by apc and one further patient experienced a recurrence after an mbm was treated by mbm.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the 27-jul-2020, this supplement report is being submitted to include the investigation conclusions.The date of event has been updated to reflect the date this literature was published.

• 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: 9910671
• MDR Text Key: 196738779
• Report Number: 3001845648-2020-00189
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention