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

Model Number	ENF-VT2
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the rhino-laryngo videoscope exhibited foreign material coming out of the channel tube.There were no reports of patient involvement.
Additional Manufacturer Narrative
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.
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, the foreign object was not identified.The root cause of the foreign object residue in the device could not be identified.For reprocessing, the gfe results confirmed that cleaning, disinfection, and sterilization were completed before returning the actual product to olympus.Regarding the details of the reprocessing performed at the facility, the gfe results did not confirm any obvious deviations from the procedures described in the instruction manual.For the identification of the foreign object in phenomenon (1), the gfe results confirmed that the facility responded that they had no idea what the foreign object was.For physical damage to the device, the device inspection results confirmed that a pinhole occurred in the forceps channel.However, the association with the foreign material residue cannot be determined because there is information that the facility had completed the reprocessing before returning the actual product to olympus.According to the instruction manual at the time of shipping the product, there are descriptions of the reprocessing below: chapter 6 "compatible reprocessing methods and chemical agents" chapter 7 "cleaning, disinfection, and sterilization procedures" chapter 8 "cleaning, disinfection, and sterilization procedures for reusable parts and reprocessing equipment" chapter 9 "cleaning and disinfection equipment" 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: 18681442
• Report Number: 3002808148-2024-01267
• Device Sequence Number: 17691020
• Product Code: EOB
• UDI-Device Identifier: 04953170339509
• UDI-Public: 04953170339509
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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-VT2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2013
• 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