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

Model Number	ENF-VT3
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the videoscope was not cleaned properly.The issue occurred during demonstration.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.An olympus endoscopy support specialist (ess) assisted the customer by connecting with a steris representative to determine what ¿aer¿ connectors were needed for reprocessing the upcoming demo enf-vt3 (after demo cds in-service was completed).Customer reported their model of aer allowed modified cleaning steps and reported that they put scopes into aer after channel brushing.A steris/medivator representative later stated that this model of aer is not actually cleared for modified cleaning and the customer should still be performing aspiration and channel flushing (or using scope buddy plus) prior to aer.Ess emailed the customer with this information and connected the customer with a steris/medivator representative so their infection prevention representative can deliver in-service on their current aer and scope buddy plus products.Ess informed the customer that per olympus flex endoscope ifus, they will need to perform aspiration and manually flush channels if they are not using scope buddy plus for these functions.Based on the results of the investigation, the root cause of the issue was improper reprocessing.The event can be detected and prevented by following the instructions for use: instructions rhino-laryngo videoscope olympus enf-vt3 reprocessing manual chapter 7 reprocessing endoscopes and accessories using an automated endoscope reprocessor/washer- disinfector 7.1 reprocessing endoscopes and accessories using an automated endoscope reprocessor/washer-disinfector follow the workflow described in section 4.3, ¿workflow for cleaning and disinfecting endoscopes and accessories using an aer/wd¿ when reprocessing endoscopes and accessories with an aer/wd.Be sure to attach all required connectors to the endoscope and accessories.For details concerning appropriate connectors, refer to the instructions of the aer/wd manufacturer.Manually clean and disinfect any endoscopes and accessories that are not compatible with the aer/wd.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: 19617985
• Report Number: 3002808148-2024-05824
• Device Sequence Number: 20409653
• Product Code: EOB
• UDI-Device Identifier: 04953170411526
• UDI-Public: 04953170411526
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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