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

Catalog Number DT-6-5F

Device Problem Device Reprocessing Problem (1091)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "deployed bands, found in scope after 12 cases.Must have been lodged in the scope.".

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: (b)(4).This complaint is related to pr225172 which is the initial complaint in which the duette device was used.This complaint is one of the 12 complaints that was raised to address the potential cross contamination across multiple patients as a precautionary measure.(1 device, 13 complaints).Date endoscope used pr opened on (b)(6) 2018, 225172 (duette used in this procedure), on (b)(6) 2018, 225329 & 225330, on (b)(6) 2018, 225331, on (b)(6) 2018, 225332 & 225333, on (b)(6) 2018, 225334 & 225335, on (b)(6) 2018, 225336 & 225337, on (b)(6) 2018, 225338 & 225339 & 225340 (band came out of scope with a biopsy forceps).There is no device related to this complaint.This complaint deals with the potential for cross contamination across the patients.Root cause: the reason for the potential cross contamination across the 12 patients is due to insufficient cleaning of the endoscope.The root cause is user error as the customer did not effectively clean the endoscope.Clinical input: clinical were contacted to provide input with regards to the potential cross contamination and provided the following feedback if the endoscope is cleaned appropriately as per reprocessing and infection control guidelines, there would be no risk of transmission of patient-borne or environmental microorganisms.The transmission rate of infection by a gi endoscope was estimated to be 1 in 1.8 million.Gastrointest endosc 1993;36:885-8 every reported case of hospital acquired infection associated with a contaminated gastrointestinal (gi) endoscope has been linked to a breach or violation of at least one of several requisite reprocessing steps.World journal gastroenterology, 12(25), 3953-3964.Hospital staffs, in this current case, might have been using machines as washer-disinfectors which do not require prior manual cleaning and channel brushing.However, the manual washing and brushing of all accessible channels has always been a critical step prior to performing high level disinfection.Asge emphasizes steps in endoscope reprocessing.According to endoscope cleaning instructions from manufacturer (e.G.Olympus), be sure to brush the inside of the suction channel.To sum up, the potential cross contamination risk is highly unlikely; the reason the band was being left in the endoscopic channel might be due to the absent usage of brush; even if there was cross contamination, that would have been clean procedure related, not device (i.E.Band) related.Summary: the customer complaint is confirmed based on the customer's testimony.This is a user error complaint due to ineffective cleaning of the endoscope.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

Although the root cause was un-related to the cook device, adopting a cautious approach a report is being submitted as a cook device was involved and there was potential risk of cross-contamination.As reported to customer relations, "deployed bands, found in scope after 12 cases.Must have been lodged in the scope.".

• 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: 7529686
• MDR Text Key: 109235638
• Report Number: 3001845648-2018-00231
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DT-6-5F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1