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

Model Number	ENF-VT3
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that the rhino-laryngo videoscope screen is black.During a standard service inspection of the customer returned device, rattling forceps cap was noted.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed due to bending of the light guide bundle.In addition, rattling forceps cap, insufficient bend angle, liquid leakage, yellowing observation, corrosion due to water leakage, grip not watertight, watertightness not maintained, video cable leak, and video connector case discoloration were observed.Lastly, scratches were found on multiple device components.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to stress or user¿s handling.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15741312
• Report Number: 3002808148-2022-03872
• Device Sequence Number: 6317313
• Product Code: EOB
• UDI-Device Identifier: 04953170399640
• UDI-Public: 04953170399640
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/06/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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