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 Hemorrhage/Bleeding (1888); Blood Loss (2597)

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.[alvarez herrero - safety and efficacy of multiband mucosectomy in 1060.Pdf].

Event Description

Study title: safety and efficacy of multiband mucosectomy in 1060 resections in barrett's esophagus.Http://dx.Doi.Org/10.1055/5-0030-1256095.Origin: (b)(6).Date aware: 04-mar-2020.Customer entity: (b)(6) medical center, (b)(6), or the (b)(6) hospital, (b)(6).Device: duette (dt-x).Complaint details: clinically insignificant bleeding obscuring the endoscopic view and therefore requiring endoscopic hemostasis during the mbm procedure was seen during 49/243 procedures (20% [95 %cl 15% - 25 %]).Hemostasis was achieved by focal coagulation of the bleeding vessel with the tip of the snare (32 procedures), apc (3), electrosurgical hemostatic forceps (1), clip (7), adrenaline (1), or a combination of these therapies (5).These bleedings were not considered to be acute complications but were regarded as events intrinsic to the resection, since the management of the patient did not alter: none of the bleedings resulted in hospital admission, blood transfusion, or repeat endoscopic intervention,and all of these patients were discharged after the normal postprocedural observation period of 2 -4 hours.

Event Description

The investigation was concluded on the 20-jul-2020, this supplement report is being submitted as a cancellation report.On review of the completed investigation it was concluded that the 'clinically insignificant bleeding' was a foreseeable complication of the procedure.These bleedings were not considered to be acute complications but were regarded as events intrinsic to the resection and not related to the use of the device.The management of the patient did not alter: none of the bleedings resulted in hospital admission, blood transfusion, or repeat endoscopic intervention and all of these patients were discharged after the normal postprocedural observation period of 2 -4 hours.Hemorrhage is also a potential side effect listed in the ifu.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.The date of event has been updated to reflect the date the literature was accepted.

Manufacturer Narrative

The investigation was concluded on the 20-jul-2020, this supplement report is being submitted as a cancellation report.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 esophagus" multiple complaint files were opened as a result of this paper.This file was opened to investigate the clinically insignificant bleeding obscuring the endoscopic view and therefore requiring endoscopic hemostasis during the mbm procedure was seen during 49/243 procedures (20% [95 %cl 15% - 25 %]).Hemostasis was achieved by focal coagulation of the bleeding vessel with the tip of the snare (32 procedures), apc (3), electrosurgical hemostatic forceps (1), clip (7), adrenaline (1), or a combination of these therapies (5).These bleedings were not considered to be acute complications but were regarded as events intrinsic to the resection, since the management of the patient did not alter: none of the bleedings resulted in hospital admission, blood transfusion, or repeat endoscopic intervention and all of these patients were discharged after the normal postprocedural observation period of 2 -4 hours.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.Summary: complaint is confirmed based on customer testimony.These bleedings were not considered to be acute complications but were regarded as events intrinsic to the resection, since the management of the patient did not alter: none of the bleedings resulted in hospital admission, blood transfusion, or repeat endoscopic intervention and all of these patients were discharged after the normal postprocedural observation period of 2 -4 hours.Complaints of this nature will continue to be monitored for potential emerging trends.-.

• 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: 9909558
• MDR Text Key: 196902895
• Report Number: 3001845648-2020-00178
• 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: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention