MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problems Poor Quality Image (1408); Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center followed up with the user facility regarding the reported event and was informed that the pre-cleaning is done immediately after a procedure using olympus required steps.The cleaning solutions used with the endoscope is prolystica / steris and the minimum effective concentration is being checked for each use.The mu1 olympus leak tester is used prior to manual cleaning.A single use brush, olympus maj-1888 / single use cleaning bw -412t is used during manual cleaning.The customer ultrasonic 83 plus sn# (b)(4) is the type of aer being used to reprocess the endoscope.There have been no problems noted with the aer and the last preventive maintenance (pm) for the aer was (b)(6) 2020.Cidex opa asp johnson & johnson is the disinfectant solution used with the endoscope and the minimum effective concentration is being checked for every use.The last reprocessing in-service conducted by an olympus endoscopy support specialist was done on (b)(6) 2020.No changes in the facilities reprocessing personnel and all reprocessing personnel are trained on how to properly reprocess an endoscope.The scope was returned to the service center and is pending evaluation.A review of instrument history showed that the scope was last returned for service on (b)(6) 2019 due to a fluid leak.

Event Description

The service center was informed that during the receipt inspection, the camera part of the scope had a blurry image.The ercp scope was sampled and cultured positive for a gram negative rod microorganism by the user facility.This device was not used on a patient with known infection of the same microorganism.The user facility reported that normal practice triggered the device sampling and culturing.The scope was reprocessed on (b)(6) 2020.The environmental culture method was used for testing the scope and the scope was not eto sterilized.There was no patient involvement, patient infection related to this device.

Manufacturer Narrative

This supplemental report is being submitted to provide the ess visit, device evaluation and legal manufacturer investigation.The scope was returned to the service center for evaluation.A cut was noted on the scope¿s switch #1.Minor chips were noted on the scope¿s control body.The light guide tube was inspected and found to be slightly collapsed.Minor chips were noted on the scope¿s connector.The scope¿s id chip showed 403 total uses.On january 7, 2021, endoscopy support specialist (ess), endoscopy account manager, and endotherapy territory manager visited (b)(6) medical center to provide an in-service.The ess covered pre-cleaning, leak testing, and manual cleaning.The ess covered all steps per the olympus reprocessing manual.The in-service went as planned.The ess did not note any deviations with the user facility¿s reprocessing methods.After the in-service, the ess emailed the on-track to the customer.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.(b)(6) reported that the most probable cause for the reported event is as follows: though it is difficult to specify, we presume the cause of germs detected as follows: reprocessing method conducted by the user and recommended by ifu are possibly different, which caused insufficient reprocessing.Occurrence of contamination during sampling for culture test.Ifu states as follows: reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.It was confirmed the subject scope was shipped in accordance with specifications via dhr.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10959778
• MDR Text Key: 226935880
• Report Number: 8010047-2020-09944
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1