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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

Annex g: (b)(4): stent.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Serrero, 2020, duette, ¿cuffitis: is an endoscopic approach possible?¿ the endoscopy performed concluded that there was probable cuffitis with the presence of a strip measuring 1 ¿ 2 cm of congestive rectal mucosa in the supraanal area that bled in contact with the endoscope.The biopsies performed were compatible with the lesions of active uc.It was thus decided to adopt an endoscopic approach.The resection was carried out by mucosectomy with the duette system (cook medical, (b)(6) united states) and a gastroscope (pentax, (b)(6)) with a large operating channel (3.8mm) for the second patient, the initial diagnostic approach revealed the presence of approximately 1cmof rectal mucosa upstream of the anal canal.A mucosectomy was then performed on 4 /5 of the circumference under the anastomosis and above the pectinate line using 10 elastic bands delivered by the duette system (cook medical) using a cap and resection technique.The pathological analysis concluded that there was the presence of pseudo-polypoid inflammatory colic mucosa, with cytological modifications that were dystrophic but not dysplastic.On day 1 following the procedure, the patient presented with occasional episodes of anal bleeding.There was no need for a transfusion and there was no hemodynamic instability.No hemostatic agents were required, and the treatment consisted of simple monitoring during a 5-day hospitalization period.The patient did not present any further rectal bleeding in the following 6 months, but does have iron deficiency anemia requiring repeated intravenous injections.This complaint is capturing 1 case of occasional anal bleeding in patient #2, as per input received from the medical advisor, the bleeding was related to duette device.However, it was off-label use in lower gi.Patient outcome: on day 1 following the procedure, the patient presented with occasional episodes of anal bleeding.There was no need for a transfusion and there was no hemodynamic instability.No hemostatic agents were required, and the treatment consisted of simple monitoring during a 5-day hospitalization period.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Device evaluation the duette device of unknown rpn and 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.¿cuffitis: is an endoscopic approach possible?" complaint files (b)(4) were opened as a result of this paper.327196 covers ¿patient #2: occasional anal bleeding¿.327197 covers ¿patient #3: slight bleeding¿.Lab evaluation ¿ n/a.Document review: as the rpn and lot number is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution dt devices are subjected to a visual inspection and functional checks to ensure device integrity.It should be noted that the instructions for use (ifu0026-10) states the following: ¿this device is for endoscopic mucosal resection in the upper gi tract¿ the article states ¿a mucosectomy was then performed on 4/5 of the circumference under the anastomosis and above the pectinate line using 10 elastic bands delivered by the duette system (cook medical) using a cap and resection technique.¿ image review ¿ n/a.Root cause review: a definitive root cause can be attributed to the off-label use of the device, when the device is used outside its stated intended use it may lead to outcomes that were never intended to happen and were never studied.The device was used off-label as it was used in the lower gi tract as opposed to the upper gi as is instructed in the ifu.Summary: the complaint is confirmed based on customer testimony.Long term success was achieve, no additional adverse events were reported to the patient as a result of device use.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
• 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: 11639874
• MDR Text Key: 261735841
• Report Number: 3001845648-2021-00294
• 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: Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2021
• 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): Hospitalization
• Patient Age: 26 YR
• Patient Sex: Male