MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number	URF-V
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s reported allegation was reproduced.In addition, the device evaluation found that due to clogging of the channel tube, the forceps could not be inserted or inserted smoothly, and the channel cleaning brush could not be inserted or inserted smoothly, the image was not displayed due to a damage on the charge coupled device unit and due to a scratch on the electrical contact of the video connector, due to physical stress, there were scratches noted on various locations.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 that there was a foreign object present near the exit of the forceps tip of the videoscope.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.Updated fields: b3, h6.A correction to the h4 device manufacturing date field was made.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation.The customer's allegation was confirmed.Based on the results of the investigation, the foreign material could not be identified.A definitive root cause for the remaining foreign material could not be established.The event can be detected and prevented by handling the device in accordance with the following sections of the instructions for use which state: chapter 6 applications and conditions for cleaning, disinfection and sterilization.Chapter 7 cleaning, disinfection, and sterilization procedures.Chapter 8 care of equipment used for cleaning, disinfection, and sterilization.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Common Device Name: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18503333
• Report Number: 9610595-2024-00813
• Device Sequence Number: 12773766
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072957
• 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): 02/17/2024

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: URF-V
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2008
• 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