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 device was returned to olympus for evaluation.And the customer's allegation was able to be confirmed.During the device evaluation it was observed, that the forceps plug cap was scraped.Additionally, the forceps channel port was detached; due to physical stress.Due to the shaved forceps channel port; water tightness was lost.Upon further inspection, it was observed, that the adhesive on the bending section cover had a chip; due to chemical or physical stress.It was also observed, that the bending angle in the up direction did not meet the standard value; due to wear of the angle wire.It was observed, that the venting connector under the grip had corrosion; due to deterioration or due to chemical stress.Lastly, scratches were observed on the following unit components, due to physical stress caused by a handling problem: connecting tube, eyepiece, diopter ring, control unit, grip, up-down plate, lock engagement lever and on the angulation lever.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the oes cystonephrofiberscope has a broken forceps mouth.The reported issue occurred, during reprocessing prior to preparation of use for an unknown procedure.The procedure was subsequently completed with an unspecified device.There was no patient/user harm or injury reported due to the 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 root cause of the event was unable to be identified; however, the event likely occurred due to mishandling at the facility.The event can be detected/prevented by following the instructions for use which state: "do not bend or hit the distal end, insertion tube, bending section, operation section, light guide, miniature light source, or rechargeable miniature light source of the endoscope with strong force in order to prevent device failure, damage, or parts from falling off., do not pull, twist or drop." 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 (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: 16872823
• Report Number: 3002808148-2023-04561
• Device Sequence Number: 12213862
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 04/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2007
• 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