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 evaluated and evaluation found forceps channel port was shaved and water tightness was lost.In addition to reportable finding mentioned in reportable event description, the device evaluation found following findings: venting connector under grip was shaved; indication on light guide connector was unclear; up/down angulation lever plate, grip and eyepiece were sticky; the control unit was dirty due to water leakage; the angle wire became longer than normal; due to wear of an angle wire, bending angle in up direction did not meet the standard value and a foggy image occurred in the view field of eyepiece.Scratches were found on the connecting tube, angulation lever, forceps lever, the diopter ring, image guide protector, the control unit, eyepiece and on the grip.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.Establishment name: social welfare corporation goodwill welfare association international goodwill general hospital (edited in respective field due to character limitation).
Event or Problem Description
The customer reported to olympus that there was a leak, isolation found on the cystonephrofiberscope.There were no reports of patient harm associated with the event.The device was returned for evaluation.During the device evaluation found the forceps stopper had came off.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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 forceps stopper had come off due to physical stress.The event can be detected/prevented by following the instructions for use which state: ¿caution ¿ never coil the endoscope¿s insertion tube, with a diameter of less than 10 cm.The endoscope can be damaged if coiled too tightly.¿ do not strike the distal end of the endoscope.There is a risk of visual field abnormalities.¿ do not twist or bend the bending section with your hands.Equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.¿ 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: 18253363
• Report Number: 3002808148-2023-13616
• Device Sequence Number: 7059448
• Product Code: FAJ
• UDI-Device Identifier: 04953170292521
• UDI-Public: 04953170292521
• 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): 12/20/2023

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: 11/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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