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

Model Number	ENF-V4
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the rhino-laryngo videoscope had blisters on the bending section and insertion part.The issue occurred during reprocessing.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: b5, h6 "health effect - impact code." a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.The device was not returned to olympus for inspection, however photos of the device were reviewed and the customer's complaint of blisters (air bubbles) on the bending section rubber and inserting part was confirmed.Based on the results of the investigation, the cause of the blisters (air bubbles) on the bending section rubber and inserting part could not be identified.However, the customer also used ultraviolet-c (uv-c) cleaning equipment (made by uv-smart, d60) for reprocessing.It is a new disinfector that uses ultraviolet-c (uv-c) radiation for 60 seconds, this likely led to the formation of blisters on the device.The following is included in the instructions for use (ifu): ¿ only olympus-recommended or olympus-endorsed aers have been validated by olympus.When using an automatic endoscope reprocessor (aer) that is not recommended by olympus, the manufacturer of the automatic endoscope reprocessor (aer) is responsible for validating compatibility of the aer with each olympus endoscope, accessories and medical instruments.¿ only use the automatic endoscope reprocessor (aer) that meets the requirements of the relevant parts of iso 15883 series in the member states of the eu.¿ before using an automatic endoscope reprocessor (aer), confirm that it is capable of reprocessing the endoscope.Be sure to attach all required connectors.Otherwise, insufficient reprocessing may pose an infection control risk.If you are uncertain as to the ability of your automatic endoscope reprocessor (aer) to reprocess the endoscope, contact the manufacturer of the automatic endoscope reprocessor (aer) for specific instructions and information on compatibility and required connectors.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
There were no reports of patient involvement.
Additional Manufacturer Narrative
It was confirmed that what was first reported as "blisters" were actually fixated proteins that had changed color.There was information stating that the dirt/foreign material was removed by cleaning.According to the additional information obtained on 2024/9/4, the facility also uses a glutaraldehyde machine, and it was mentioned that the dirt/foreign material was fixated proteins.It was also mentioned that glutaraldehyde is a very well-known protein fixator.It was concluded that the uv-light discolored the fixated proteins.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: 19192510
• Report Number: 3002808148-2024-03918
• Device Sequence Number: 7620825
• Product Code: EOB
• UDI-Device Identifier: 04953170411380
• UDI-Public: 04953170411380
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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-V4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 09/25/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/21/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: D60-UV-SMART (NON-OLYMPUS).
• Patient Sex: Unknown