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

Model Number	ENF-V4
Medical Device Problem Code	Device Reprocessing Problem (1091)
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.Related patient identifiers: (b)(6).
Event or Problem Description
It was reported, the rhino-laryngo videoscope exhibited blisters on the bending section rubber and inserting part.The issue occurred during reprocessing.There were no reports of patient harm.
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
Based on the legal manufacturer's final investigation results, it was found that the blisters meant the dirt/ foreign material adhered to the endoscope.The foreign material was removed by cleaning.The facility used a glutaraldehyde machine and it is known to be a protein fixator.The manufacturer of the wd-machine and the uv-c manufacturer concluded that the ultra violet light discolored the fixated proteins.The instructions for use manual stated: only olympus-recommended or olympus-endorsed automatic endoscope reprocessor (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.Since the device was not returned to olympus, it could not be inspected.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported the rhino-laryngo videoscope had fixated proteins on the bending section rubber and inserting part.The issue occurred during reprocessing.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
Updated fields: h11.This supplemental report is being submitted to provide the results of 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 1 year since the subject device was manufactured.Based on the results of the investigation, a definitive root cause for the reported suggested malfunction could not be established.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: 19279764
• Report Number: 3002808148-2024-04291
• Device Sequence Number: 7669127
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2024

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?: Yes
• 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; 09/20/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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
• Patient Sex: Unknown