MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number	CYF-5A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cystonephrofiberscope had a pinhole on its bending section cover.There was no report of patient harm.The device was returned, evaluated, and it was found that the forceps plug mouthpiece was scraped.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the reported event was confirmed.It was found that water tightness was lost due to a pinhole on the bending section cover.In addition to the forceps plug mouthpiece being scraped, other evaluation findings are as follows: the adhesive on the bending section cover was chipped; the bending angle in the up direction did not meet the standard value due to wear of the angle wire; the grip and the upward/downward plate were discolored; and the venting connector under grip was shaved.Lastly, there were scratches on the following parts: the eyepiece, the connecting tube, the diopter ring, the control unit, the grip, the forceps elevator lever, the angulation lever, and the image guide protector.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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 nine years since the subject device was manufactured.Since the actual product was not returned to the legal manufacturer, and the detail condition of the actual product cannot be confirmed, occurrence cause and root cause of the forceps plug mouthpiece being scraped could not be identified from information obtained by investigation.Olympus will continue to monitor the field performance of this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Common Device Name: CYSTONEPHROFIBERSCOPE
• 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: 17472243
• Report Number: 3002808148-2023-08034
• Device Sequence Number: 7415729
• Product Code: FAJ
• UDI-Device Identifier: 04953170286964
• UDI-Public: 04953170286964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032092
• 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): 08/09/2023

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown