MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the evis exera iii gastrointestinal videoscope after clean-up, the instrument was found to be contaminated during repeated microbiological checks.On 13oct2023, the device tested positive for 6 colony forming units (cfus) of micrococcus and also detected coagulase-negative staphylococci.On 20oct2023, the device tested positive for 2 cfus of micrococcus.On 18oct2023, the device tested positive for less than 1 cfus of an unspecified bacteria.On 20oct2023, the device tested positive for 2 cfus of micrococcus.On 27oct2023, the device tested positive for 7 cfus of micrococcus.All channels were sampled on all days.The user did not report any contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

This report is being supplemented to provide additional information based on results of third-party testing, the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: <1cfu.Additional details were received regarding the cleaning disinfection and sterilization practices (cds) of the user where: there is no suspected patient infection and there are no apparent deviations, deficiencies, or concerns with reprocessing.Manual disinfection: the device is rinsed before manual disinfection.Tristel fuse is the disinfectant used.All channels flushed with and immersed into the disinfectant.Automatic disinfection: an stella reprocessor is used with anioxyme x3 detergent and tristel fuse disinfectant.There were no defects on the automatic endoscopic reprocessor (aer).All channels were connected with cleaning tubes when the endoscope was setting up into the aer.The disinfectant was used within its expiration date.The minimum effective concentration (mec) of the disinfectant solution was meet.The water quality of the rinse water was not controlled.Storage: the device is blown dry with filtered air.The device is stored in sterile storage.The device was evaluated where no abnormalities were found that could have led to the positive culture.A few defects were noted where the channel mount and the insertion section mount have wear and damage.However, these defects alone are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The reprocessing method is described in the following chapters of the instructions for use: chapter 4 reprocessing workflow for endoscopes and accessories.Chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 18196255
• MDR Text Key: 330432704
• Report Number: 3002808148-2023-13282
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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