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

Model Number	CYF-VHA
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
Event or Problem Description
During the device inspection, the tip of the videoscope was missing.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Updated h3 and h4.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, as the device was not returned to the plant, the reported malfunction could not be reproduced.However, a definitive root cause could not be determined.The event can be detected and prevented in accordance with the following instructions for use (ifu).Operating instructions bladder and pelvis videoscope olympus ltd-vha safety instructions ¿ do not bend the flexible part of the endoscope, the universal cord, or the video cable in small increments (diameter less than 10 cm), as this may cause damage.¿ do not twist or bend the insertion tube of the endoscope with excessive force, as this may cause damage to the insertion tube.¿ do not subject the tip of the endoscope, especially the lens surface, to any impact, as this may cause abnormalities in the endoscopic image.¿ if the endoscope is dropped or the tip receives a strong impact, some type of damage may have been caused even if the lens at the tip is not scratched or chipped.Stop using the endoscope and contact olympus.¿ do not twist or bend the curved section by hand, as this may cause damage.¿ do not squeeze the curved part too hard, as this may stretch or tear the covering material on the curved part, resulting in water leakage.¿ during transportation or reprocessing, do not place or press the video connector or light guide connector onto the insertion tube, as this may cause damage.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of 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: 20593044
• Report Number: 3002808148-2024-10733
• Device Sequence Number: 8797072
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: Other
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2018
• 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