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 (2263)

Event Date 11/16/2010

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Symptomatic stenosis occurred in 33 patients and only after procedures that were part of the (stepwise) radical resection protocol (33/69 patients; 48% [95 %cl 36 %- 60 %]).Stenosis was graded as 'moderate' in 24 patients (resolving after 5 dilations) and 'severe' in 9 patients (as more than 5 dilations, incision therapy, or stent placement was necessary).

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."alvarez herrero-safety and efficacy of multiband mucosectomy in1060 resections in barrett's esophagusf" multiple complaint files were opened as a result of this paper.This file was opened to investigate the symptomatic stenosis occurred in 33 patients and only after procedures that were part of the (stepwise) radical resection protocol (33/69 patients; 48% [95 %cl 36 %- 60 %]).Stenosis was graded as 'moderate' in 24 patients (resolving after 5 dilations) and 'severe' in 9 patients (as more than 5 dilations, incision therapy, or stent placement was necessary).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 dt-6 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.As the duette devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.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.Symptomatic stenosis occurred in 33 patients and only after procedures that were part of the (stepwise) radical resection protocol (33/69 patients; 48% [95 %cl 36 %- 60 %]).Stenosis was graded as 'moderate' in 24 patients (resolving after 5 dilations) and 'severe' in 9 patients (as more than 5 dilations, incision therapy, or stent placement was necessary complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the 20-jul-2020, this supplement report is being submitted to include the investigation conclusions.The date of event has been updated to reflect the date the literature was accepted.

• 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: 9909776
• MDR Text Key: 189591316
• Report Number: 3001845648-2020-00181
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2010
• Event Location: Hospital
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention