MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number	CYF-VHA
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 device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported to olympus that a telescope had foreign matter falling from the channel.It is unknown when the reported issue was found.The reportable malfunctions were discovered by olympus staff during evaluation of the returned device.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Correction to d5, g2 (adding other, japan), h4, h10 (reprocessing information of subject device) information was inadvertently not included on the initial medwatch.Reprocessing of subject device the customer confirmed they cleaned, disinfected, and sterilized the product before sending it to olympus.The customer did not know when the foreign material adhered to the endoscope or whether the endoscope was used for a procedure with the foreign material attached to it.The customer flushed the air/water nozzle with water and air; immersed the endoscope in the detergent solution; unknown if it was wiped/brushed the air/water nozzle with clean lint-free cloths, brushes, or sponges; and flushed the air/water nozzle with the detergent solution.The device was returned and an evaluation was completed for it.During inspection, olympus confirmed the reported event, foreign matter from the forceps channel was found.Additionally, a pinhole on the bending rubber, insufficient angle, water immersion in the control section, leaking form the ud (up/down) plate, lg (light guide) bundle, lg (light guide) tube, yellowish discoloration of the lg bundle, corrosion on the venting connector, scratches on the a-rubber (bending section cover), and deformation of the video connector and video connector cover; however, these defects are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely the foreign material from the forceps channel occurred due to insufficient cleaning (handling problem).However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿chapter 4 reprocessing workflow for endoscopes and accessories.Chapter 5 reprocessing the endoscope (and related reprocessing accessories)¿.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: CYSTO-NEPHRO 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: 16916605
• Report Number: 3002808148-2023-04775
• Device Sequence Number: 6756555
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown