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

Model Number	CYF-5A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, forceps stopper cap came off, wrinkles in insertion tube, bending angle insufficient due to elongation of the angle wire, forceps could not be inserted smoothly into the forceps channel, channel cleaning brush could not be inserted smoothly into the forceps channel, spots noted on the insertion guide bundle, liquid leakage observed in the operation part, scratches found on the operation part, scratches found on the curved rubber adhesive part, fluid leakage observed in the eyepiece, scratches found on the eyepiece, liquid leakage observed in the grip, scratches found on the grip, water tightness not maintained due to the detachment of the forceps plug mouthpiece, liquid leakage recognized on the up/down plate, scratches on the angle lever, scratches found on the fixed ring, and scratches found on the up/down angle fixing lever (sp).The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.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
A user facility submitted a repair request to the olympus service center, for an oes cystonephrofiberscope forceps channel had connection failure.Upon inspection and testing of the customer returned device, the scope forceps plug mouthpiece was detached.There was no report of patient harm or user injury associated with 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.Based on the results of the investigation, the definitive root cause of the instrument channel port detachment could not be determined.It is possible that the detachment of the instrument channel port was caused by stress, handling, or other issues.Olympus will continue to monitor field performance for 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15664634
• Report Number: 3002808148-2022-03489
• Device Sequence Number: 6498623
• 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): 12/02/2022

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: 09/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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