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

Model Number	ENF-VH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the rhino-laryngo videoscope had a water leak.The issue was found during preparation for use of an unknown therapeutic procedure.The procedure was completed using a similar set of equipment.The device was returned for evaluation.During the device evaluation, it was found that the resin part of the image guide pipe had fallen off.There were no reports of patient harm or injury.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed due to a cut on the connecting tube water tightness was lost.In addition to the reportable finding documented in b5, the non-reportable evaluation findings are as follows: connecting tube had a dent, video cable had a dent, control unit had discoloration, universal cord had a dent, bending angle in the up direction did not meet the standard value due to wear of the angle wire, light guide bundle had breakage, and multiple parts had a scratch.The investigation is ongoing and follow up with the user facility has been 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 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 loosened or detached parts joint area was caused by chemical stress or physical stress.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: 18384653
• Report Number: 3002808148-2023-14724
• Device Sequence Number: 4132930
• Product Code: EOB
• UDI-Device Identifier: 04953170434693
• UDI-Public: 04953170434693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221638
• 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): 02/03/2024

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2012
• 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