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 customer's allegation was confirmed due to damage on the objective lens, a foggy image occurred.In addition to the reportable finding documented in b5, the non-reportable evaluation findings are as follows: water tightness was lost due to a crack on the control unit, adhesives on the bending section cover had a chip, connecting tube had a dent, connecting tube had a wrinkle, bending angle in up direction did not meet the standard value due to wear of the angle wire, forceps could not be inserted because the channel tube was crushed, control unit was sticky due to water leakage, bending tube had a dent, up/ down plate was sticky, control unit was sticky, protector of the universal cord on the control section side had a cut, universal cord had a dent, eyepiece had a scratch, and the image had shadows due to damage on the objective lens.The device was returned and evaluated, both the light guide lens and objective lens had foreign objects; this has been attributed to insufficient cleaning.The device was cleaned, disinfected, and sterilized (cds) before it was sent in for repair and there was no delay in the start of precleaning.According to the customer, the following details regarding the cds process were unknown: what the foreign material was and if the customer wiped/ brushed the distal end with clean lint-free cloths, brushes, or sponges.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.
Event or Problem Description
The customer reported to olympus, the rhino-laryngofiberscope had a cloudy image.The device was returned for evaluation.During the device evaluation, it was found that the objective lens and light guide lens had foreign objects.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
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 foreign material was insufficient cleaning.Identification of the material could not be determined.Olympus will continue to monitor field performance for this device.

• 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: 18522213
• Report Number: 3002808148-2024-00491
• Device Sequence Number: 11646008
• Product Code: EOB
• UDI-Device Identifier: 04953170411076
• UDI-Public: 04953170411076
• 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
• 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-T3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/03/2024
• 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