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

Model Number	ENF-V4
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated at olympus and the customer's allegation was confirmed.The device evaluation found that due to a pinhole on connecting tube and wear of sw-cover packing, water tightness was lost.In addition to the issues from b5, the device evaluation revealed adhesive on distal sheath was detached.The connecting tube had a wrinkle.The angulation lever and color ring had a crack.The universal cord had a dent and a wrinkle.Due to wear of angle wire, bending angle in the up direction did not meet the standard value.Due to adhesive peeling around objective lens, flare or ghost occurred.Also the label on video connector was peeled.Scratches were also found on the following device components: video connector case and connector, light guide lens connector, right/left plate, grip, sw cover, control unit, and image guide protector.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that while using the rhino-laryngo videoscope, had air/water flow issues.There was no patient harm associated with the event.During device evaluation at olympus, the illumination lens and plastic distal end cover had fallen off.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
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.It has been more than 4 years since the subject device was manufactured.Based on the results of the investigation, it could not be determined if the fallout of the plastic distal end cover (c-cover) and illumination lens was caused by stress or handling, or other factors.Therefore, the root cause could not be identified.This supplemental report includes a correction from the initial medwatch.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: 16195126
• Report Number: 3002808148-2023-00524
• Device Sequence Number: 14968895
• Product Code: EOB
• UDI-Device Identifier: 04953170402456
• UDI-Public: 04953170402456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182102
• 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): 02/08/2023

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-V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2019
• 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