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

Model Number	ENF-V4
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 evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, that the rhino-laryngo videoscope had blisters on the bending section rubber and inserting part, that could be caused by an ultraviolet cleaning machine as suspected by the customer.The issue was found during reprocessing.There were no reports of patient harm as a result of this event.
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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon of "blisters" (foreign material) could not be further identified, nor why it may have remained in the device, as the device was not returned for inspection.A further cause of the suggested phenomenon therefore could not be presumed.The reprocessing manual of the instructions for use contain the following descriptions relevant to the suggested event: "warning ¿ only olympus-recommended or olympus-endorsed aers [automatic endoscope reprocessor(s)] have been validated by olympus.When using an aer that is not recommended by olympus, the manufacturer of the aer is responsible for validating compatibility of the aer with each olympus endoscope, accessories and medical instruments.¿ only use the aer that meets the requirements of the relevant parts of iso 15883 series in the member states of the eu.¿ before using an 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 aer to reprocess the endoscope, contact the manufacturer of the aer for specific instructions and information on compatibility and required connectors." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Based on the results of the investigation and available information, it is likely the following led to the malfunction: ·the customer uses uvc disinfection machine (uv-smart¿s d60) for reprocessing.The machine is a new disinfection machine that utilizes uv-c light, and the duration of uv-c light is 60 seconds.·blisters occurred in the three instruments (33.3%) out of 10 instruments among the device that used uvc disinfection machine and that was inspected.All three instruments had blisters in the similar area.·we confirmed that the instruction manual had the following descriptions.[only olympus-recommended or olympus-endorsed aers have been validated by olympus.When using an aer that is not recommended by olympus, the manufacturer of the aer is responsible for validating compatibility of the aer with each olympus endoscope, accessories and medical instruments.] olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to provide the confirmed results of the foreign material identification.The foreign material was confirmed as a protein.This information does not alter the previously provided legal manufacturer's investigation results.If additional information becomes available, a supplemental report will be provided.

• 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: 19281201
• Report Number: 3002808148-2024-04295
• Device Sequence Number: 7649088
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2024

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: Other
• 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: 05/20/2024; 09/19/2024; 10/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/29/2024; 10/04/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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