MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number	ENF-VT3
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The customer reported that there was a possibility that the brushing around the forceps mouthpiece was insufficient, but that improvements and countermeasures have already been taken in the hospital in accordance with the manual.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings and the device was quarantined.The customer provided the cleaning, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure.Water was aspirated through the forceps/suction channel using a suction pump.The device passed the leak test.The forceps/suction channel, suction cylinder, and forceps port were brushed.The automated endoscope reprocessor (aer) used was olympus oer-5 with endo quick detergent and aceside disinfectant.There were no problems reported with the aer and all channels were connected when the device was being set up into the aer.The concentration and expiration date of the disinfectant were controlled.The water quality was controlled and the filter was not replaced periodically in accordance with the instructions for use.The device was dried by wiping with a clean towel/paper and stored in storage without a drying function, at room temperature and ambient oxygen concentration.Olympus is the maintenance company.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that during routine microbiological testing, the rhino-laryngo videoscope tested positive for moraxella atlantae and bacillus spp at the forceps mouthpiece.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 and because the subject device was not returned, the reported event could not be confirmed and a root cause could not be determined.The reported event was not confirmed as the scope was not microbiologically tested by olympus.According to reviewing the instruction manual for enf-vt3, cleaning / disinfection / sterilization, the reprocessing methods are described in the following chapters: chapter 3 compatible reprocessing methods and chemical agents; chapter 4 reprocessing workflow for endoscopes and accessories; chapter 5 reprocessing the endoscope (and related reprocessing accessories); chapter 7 reprocessing endoscopes and accessories using an automated endoscope reprocessor/washer-disinfector.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Common Device Name: RHINO-LARYNGO 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: 17935538
• Report Number: 3002808148-2023-11274
• Device Sequence Number: 20433387
• Product Code: EOB
• UDI-Device Identifier: 04953170411526
• UDI-Public: 04953170411526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: ENF-VT3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown