MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

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

Patient Problem Bacterial Infection (1735)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

The subject scope was not returned to the service center for evaluation.A review of the service history indicates the scope was purchased on (b)(6) 2013.There was one service event through an advance replacement program on december 24, 2018 for a scope that failed the leak test.The records indicate the user facility received a replacement scope but there is no record that shows the scope that failed the leak test was returned in exchange.As part of the investigation, an endoscopy service specialist (ess) visited the user facility and conducted an observation and an in-service regarding the reprocessing practice.The ess observed the staff was not using a leak tester, a channel brush, and incorrectly performing the high level disinfection process.The ess provided the user facility with reprocessing wall chart guides and trained the staff on how to properly perform pre-cleaning, leak testing, manual cleaning, and manual high level disinfection.The ess informed the user facility of the needed equipment such as leak tester and channel cleaning brush.Additionally, the user facility will plan on purchasing additional equipment in order to take into account the reprocessing time required for the scope to be patient ready.This reported event has been reported by the importer on mdr# 2951238-2019-01190.

Event Description

The manufacturer was informed that 24 hours after a cystoscopy procedure, the patient had a fever and needed to be hospitalized.The patient's urine culture indicated that the patient contracted pseudomonas aeruginosa >100,000 cfu/ml.The patient's urine culture on (b)(6) 2019 and prior to the procedure indicated that everything was normal.The facility utilizes aldahol for reprocessing and the aldahol's efficacy is tested daily.

Manufacturer Narrative

As part of the investigation, the scope was sent to an independent laboratory for microbial testing.The reported pseudomonas aeruginosa was not identified, however, the scope's instrument/suction channel tested positive for bacillus megaterium.The scope will be ethylene oxide (eto) sterilized and returned to the service center for a physical evaluation.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found the investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Since the test conducted at the independent laboratory was positive for culture, it is likely that there was a breeding ground for bacteria in the subject device, and that this phenomenon occurred because bacteria was used for patients while it was left behind.The legal manufacturer determined that most probable causes are as follows: there was an inappropriate reprocess in your facility, such as not using leak testers.This resulted in insufficient cleaning, leaving bacteria behind.The subject device was damaged by internal exposure due to a bend rubber tear, etc.As a result, the brushes did not reach the area concerned during cleaning, resulting in insufficient cleaning, and bacteria remained.These factors could have been prevented by reprocess according to the instruction manual or by pre-use inspection.From the above, it is considered that this phenomenon was caused by the handling of the user.As stated on the ifu and as a preventive measure, the user manual states: warning "after using this instrument, reprocess and store it according to the instructions given in chapter 5, "reprocessing: general policy" through chapter 8, "storage, transporting and disposal".Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection." chapter 3 preparation and inspection (p.23) warning "using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage." olympus will continue to monitor complaints for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9350372
• MDR Text Key: 181477914
• Report Number: 8010047-2019-04034
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention