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

Catalog Number DT-6-5F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

I received call from erbe rep who told me that she had been told by staff that they have been getting one to two bleeds per week when they use the duette.She has checked the erbe diathermy machine & the machine is working ok.Rep update ( 07/10/2020): cook received a call from a erbe rep who told us that she had been told by staff at (b)(6) hospital that they have been getting one to two bleeds per week when they use the duette.She has checked the erbe diathermy machine & the machine is working ok.She believes the settings on the erbe machine they were using was endocut.I and my colleges have contacted other duette end users and enquired what erbe settings they currently use and i have forwarded that information onto (b)(6) at the (b)(6) research centre.I have spoken with (b)(6) who is the senior research sister and is unable to provide me with any dates of occurrences or any lot numbers of our duette.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.( not sure).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.( not sure).

Manufacturer Narrative

Device evaluation: the dt-6-5f device of lot number unknown involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all dt-6-5f devices are subject to visual 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) states the following: ¿potential complications 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 the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause can be attributed to a procedural related effect as per the instructions for use (ifu0026-10) haemorrhage is a known complication associated with the use of the device.Summary: the complaint is confirmed based on customer testimony.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

Final mdr report being submitted due to the completion of the investigation on 21-oct-21.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10722080
• MDR Text Key: 212720104
• Report Number: 3001845648-2020-00814
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DT-6-5F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention