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.

• 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: heather ryan ; o halloran road; national technology park; 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
• Reporter Occupation: Other Health Care Professional
• 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

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2010
• Event Location: Hospital
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/01/2020 Patient Sequence Number: 1