MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

Device Problems Break (1069); Structural Problem (2506)

Patient Problems Oversedation (1990); No Information (3190)

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.(b)(4).Origin: (b)(6).Date aware: (b)(4) 2020.Customer entity: (b)(6) medical center, (b)(6), or the (b)(6) hospital, (b)(6).Device: duette (dt-x).Complaint details: technical problems occurred during 2/243 mbm procedures (1 %[95 %cl 0% -3 %]).In one patient a 5-fr snare broke during the resection; the resection was completed without further problems using a new 7-fr snare.

Manufacturer Narrative

Customer entity: academic medical center, amsterdam, or the sint antonius hospital, nieuwegein, the netherlands the duette device of unknown lot number 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 attached journal article.Reference "alvarez herrero-safety and efficacy of multiband mucosectomy in1060.Pdf" this file was opened to investigate one patient with a 5-fr snare broke during the resection; the resection was completed without further problems using a new 7-fr snare.As the rpn and lot number of the complaint device 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.The instructions for use, which accompanies this device instructs the end user ¿ fully retract and extend the snare to confirm smooth operation of the device.¿ also " with pseudopolyp in the endoscopic view, introduce the sheath and retracted snare into the white seal of the handle of the multi-band ligator.Advance the device, in small increments, until it is endoscopically viewed exiting the endoscope." " advance the snare wire out of the sheath and position it around the pseudopolyp to be removed." there is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined the device was not returned for evaluation.A possible root cause could be attributed to the snare becoming damaged during use while being advanced/retracted through the handle of the multi-band ligator.There are number of causes that may have contributed to the snare breaking.The snare's wire may have been kinked while being advanced through the scope and this force may have caused a fracture, but this is unknown.The snare may have become entangled on the trigger cord.As a result of pulling the snare free it may have broken.The most likely possibility is that the snare wire received excessive force while in use thus causing the breakage.Complaint is confirmed based on customer testimony.The patient's outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.- attachment: [alvarez herrero - safety and efficacy of multiband mucosectomy in 1060.Pdf].

Event Description

The investigation was concluded on the 17-aug-2020, this follow up mdr is being submitted to include the investigation conclusions.The date of event has been updated to reflect the date the literature was accepted.Initial complaint details: 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: netherlands.Date aware: 04-mar-2020.Customer entity: academic medical center, amsterdam, or the sint antonius hospital, nieuwegein, the netherlands device: duette (dt-x).Complaint details: technical problems occurred during 2/243 mbm procedures (1 %[95 %cl 0% -3 %]).In one patient a 5-fr snare broke during the resection; the resection was completed without further problems using a new 7-fr snare.

• 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: 9909546
• MDR Text Key: 196793067
• Report Number: 3001845648-2020-00177
• 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: 08/17/2020

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): Hospitalization