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

Catalog Number DT-6-5F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

This event is currently still under investigation.A follow up report will be submitted within 30 days with the investigation conclusions.This event is currently still under investigation.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

The last band on the duette kit was fired.The barrel came off the end of the device and lodged in the patients trachea.The patient coughed the barrel up and the procedure was abandoned.

Manufacturer Narrative

The device involved in this event was not returned for evaluation.A definitive cause for this complaint was unable to be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy or progression of disease state, cook (b)(4) could not reproduce the actual conditions of device usage.We are unable to conclusively determine the root cause of this complaint.The complaint was confirmed based on the customer¿s testimony.Prior to distribution all duette devices are subjected to visual inspection and functional checks to ensure device integrity as per cirl internal procedures.As per instructions for use ¿if the packaging is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends, breaks.If an abnormality is detected that would prohibit proper conditions do not use¿.A review of the relevant manufacturing records for the dt-6-5f (lot # c1164839) device did not reveal any discrepancy related to the complaint issue.A review of the relevant manufacturing records for the dt-mbm-6 duette multi band ligator component lot # involved in this complaint did not reveal any discrepancy related to the complaint issue.As per functional checks there is 100% inspection of the components involved (multi band ligator) completed.According to ifu caution section ¿do not place lubricant inside the barrel¿ caution ¿ do not place alcohol on the device¿ a possible root cause for this complaint could be the end user not following the system preparation or dismantling of the multiband ligator to the endoscope.As the conditions of use of the device or as device was not returned for evaluation we cannot conclusively determine if this was the root cause of the complaint.According to ifu on system preparation for the multi band ligator ¿attach the trigger cord to the hook on the end of the loading catheter ,leaving approximately 2cm of trigger cord between the knot and the hook.Withdraw the loading catheter and trigger cord up through the endoscope and out through the multi band ligator handle.According to ifu on how to dismantle the multi band ligator as follows ¿first remove the endoscope from the patient¿ remove the barrel from the endoscope tip, and then pull the trigger cord through the channel and out the endoscope tip.Prior to distribution all dt-6-5f devices are subject to visual inspection and functional checks to ensure device integrity.A section of the device did remain inside the patient¿s body.The barrel of the duette kit was coughed up by the patient the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the completion of the investigation relating to this event.Investigation details have been added to this report.Initial complaint description submitted as follows: the last band on the duette kit was fired.The barrel came off the end of the device and lodged in the patients trachea.The patient coughed the barrel up and the procedure was abandoned.

• 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 Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5334222
• MDR Text Key: 34646616
• Report Number: 3001845648-2015-00320
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K050578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DT-6-5F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2015
• Event Location: Hospital
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1