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

Model Number	ENF-T3
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
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that the connecting tube had a dent and a wrinkle, forceps couldn't be inserted smoothly due to a dent on channel tube, protector of universal cord on scope connector side had a cut, universal cord had a dent and a wrinkle, eyepiece was deformed, upward/downward angulation lever plate was deformed, angulation lever had discoloration, indication on grip was peeled, light guide rod had a scratch, and the label on scope connector was peeled.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.
Event or Problem Description
The customer reported to olympus, the rhino-laryngofiberscope eyepiece experienced leakage.The device was returned for evaluation.During the device evaluation, it was found that the channel tube contained foreign material.There were 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 foreign material could not be identified nor the root cause of it.Per additional follow up from the customer, the device was not cleaned, disinfected, and sterilized the product before it sent in for repair.The event can be detected/prevented in accordance with the following instructions for use: chapter 7 reprocessing and storage.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Upon further review by the legal manufacture, it was determined that the reportable malfunction included in the initial medwatch report with mfr# 3002808148 2024 00691 was erroneous (4048 - failure to clean adequately).Additional review revealed that the reported device problem is not a malfunction reportable product failure.Per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Corrections to medwatch fields: b1: product problem incorrectly selected.H1: malfunction incorrectly selected.H6 code 4048 - failure to clean adequately was incorrectly selected.

• Brand Name: RHINO-LARYNGOFIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• 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: 18564490
• Report Number: 3002808148-2024-00691
• Device Sequence Number: 15118451
• Product Code: EOB
• UDI-Device Identifier: 04953170318214
• UDI-Public: 04953170318214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011869
• 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,Followup
• Report Date (Section B): 02/12/2024

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-T3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 01/25/2024; 02/08/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/01/2024; 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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