MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

Device Problem Microbial Contamination of Device (2303)

Patient Problem Viral Infection (2248)

Event Type  Injury  

Event Description

An olympus representative reported to olympus, he had seen a news report on tv of a potential exposure of hepatitis b and hiv to patients at a facility where olympus equipment was potentially used.A second olympus representative reported an updated news report which stated three (3) patients tested positive for infectious diseases at the same facility.There was one (1) who tested positive for hepatitis b and two (2) patients for hiv.It was also reported the customer was not changing the chemical nor testing minimum recommended concentration (mrc) or using alcohol with 2 oer-pro machines.The olympus representative for the facility reported they were reprocessing cyf-vh urology scopes in the oer.There are no patient incidents reported.The hospital notice sent to patients was precautionary.To date, no patient harm has been reported to olympus personnel.This medical device report (mdr) is being submitted to capture the potential infections that may have been caused by olympus endoscopes reprocessed with either of the 2 oer-pros used at this facility.The following medwatch reports are related: (b)(6) - 1st oer-pro, patient 1 - hepatitis b, (b)(6) - 1st oer-pro, patient 2 - hiv, (b)(6) - 1st oer-pro, patient 3 ¿ hiv, (b)(6) - 2nd oer-pro, patient 1 - hepatitis b, (b)(6) - 2nd oer-pro, patient 2 - hiv, (b)(6) - 2nd oer-pro, patient 3 - hiv, (b)(6) - patient 1 - cyf-vh, (b)(6) - patient 2 - cyf-vh, (b)(6) - patient 3 - cyf-vh.This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.The customer reported they have external filters in their water line.Filter changes could not be verified due to poor record keeping.Water line disinfection was verified in march during the pm and was performed again during the in-service training.Disinfectant usage could not be verified.No logs were being kept.Day-to-day operation, start-of-day, end-of-day processes were not logged and could not be verified.The reprocessing area is two rooms (dirty/clean).The washers are on the clean side.The washers were in continuous use, not stored.Link to article provided by reporter.Https://www.Wsoctv.Com/news/local/9-investigates-atrium-health-alerts-man-possible-hiv-exposure-year-after-procedure/nqxvrpfpmzepphxv4p2jvqb7jy/?outputtype=amp link to second article provided by reporter.Https://www.Wsoctv.Com/news/local/9-investigates-3-test-positive-viruses-after-potential-exposure-atrium-health-urology-office/rstuksbxdzad3hb2upav46nmsm/ this report has been submitted by the importer under this mdr report number 2429304-2023-00002.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event could not be determined.Inquiries were made to the facility, but there was no response, and the patient's detailed information and outcome are unknown.Also, the following deviations from the instructions for use (ifu) were noted: disinfectant solution concentration check was not performed, and alcohol was not used.Culture testing of the device could not be performed, as the device was not returned to olympus for inspection.The event can be detected/prevented by referring to the following sections in the ifu: ¿chapter 6: compatible reprocessing methods and chemical agents.Chapter 7: cleaning, disinfection, and sterilization procedures.¿ this supplemental report includes information added to d8 and h4.Also, a correction has been made to e4 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16141526
• MDR Text Key: 307151017
• Report Number: 3002808148-2023-00316
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Device Catalogue Number: N6006040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other