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 returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found universal cord had buckling.Due to a pinhole on universal cord, water tightness was lost.Adhesive on bending section cover had a chip.Image guide protector had a cut.Angulation lever had a crack.Universal cord had a dent.Due to wear of angle wire, bending angle in up direction did not meet the standard value.Video connector case had a scratch.Video connector had a scratch.Light guide connector had a scratch.Light guide-cover glass had a scratch.Video cable had a dent.Video cable had a scratch.Right/left plate had a scratch.Switch cover had a scratch.Control unit had a scratch.Grip had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The olympus employee reported that the rhino-laryngo videoscope had buckling of the light guide corrugated tube protector.Upon inspection and testing of the returned device, it was observed that the light guide lens was missing.There was no patient involvement and no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during 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.Based on the results of the investigation, the root cause of the observed detached/missing illumination lens could not be determined.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: 16887499
• Report Number: 3002808148-2023-04645
• Device Sequence Number: 20376949
• 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): 05/26/2023

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: 04/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2019
• 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