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 Hemorrhage/Bleeding (1888)

Event Date 02/23/2010

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.User facility : department of gastroenterology and hepatology, (b)(6) hospital , (b)(6), department of gastroenterology, (b)(6) hospital , (b)(6), contact person : (b)(6) , director of gastrointestinal endoscopy , (b)(6) hospital, (b)(6).(b)(6).

Event Description

Moss-"endoscopic resection for barrett ¿ s high-grade dysplasia and early esophageal adenocarcinoma: an essential staging procedure with long-term therapeutic benefit".Immediate complications included seven cases of bleeding that were managed endoscopically with coagulation (including coagrasper, olympus, tokyo, japan), clips, or adrenaline injection.) one case of aspiration of blood required two night hospitalization with full recovery.

Manufacturer Narrative

Device evaluation: the unknown 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 "moss - endoscopic resection for barrett's high-grade dysplasia and early oesophageal adenocarcinoma: an essential staging procedure with long-term therapeutic benefit." multiple complaint files were opened as a result of this paper.This file was opened to investigate 7 cases of immediate complications of bleeding that were managed endoscopically with coagulation (including coagrasper, olympus, tokyo, japan), clips, or adrenaline injection.) 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, oesophageal 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 advisor has confirmed that the device functionality did not contribute to the issue.This effects experience were the result of the procedure being performed." these complaints were not related to device functionality and device was performed as intended use." summary: complaint is confirmed based on customer testimony.7 patients experienced cases of immediate complications of bleeding that were managed endoscopically with coagulation (including coagrasper, olympus, tokyo, japan), clips, or adrenaline injection.).Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the 28-jul-2020, this supplement report is being submitted to include the investigation conclusions.

• 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: 9915011
• MDR Text Key: 196797265
• Report Number: 3001845648-2020-00192
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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: 02/23/2010
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention