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

Model Number CYF-VHA

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, as noted in b5, the forceps stopper cap had scraping present.Additionally, the subject device had several other points of wear and tear.Those included but are not limited to wrinkles, scratches, peeling, and material deformation.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned his olympus cysto-nephro videoscope due to an angulation issue.According to the initial reporter, the angulation lock was not functioning properly, and the unit had insufficient angulation.There was no report of patient harm as a result of this event.During the device evaluation, it was discovered that the forceps stopper cap had scrapping present.This report is being submitted to capture the damage found during the device evaluation on the forceps stopper cap.

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 scratched forceps cap could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿¿ please do not flex (less than or equal to 10cm) the soft part of the endoscope, the universal code, and the video cable.Damage may occur.¿ please do not twist or bend the insertion site of the endoscope with strong force.Otherwise, the insertion section may be damaged.¿ no impact should be applied to the tip of the endoscope, especially the lens surface.Endoscope images may be abnormal.¿ if the endoscope is dropped or a strong impact is applied to the distal end, there may be some damage to the lens even if the tip is not scratched or missing.Discontinue endoscope and contact olympus.¿ please do not twist or bend the bent part by hand.Damage may occur.¿ please do not make the curvature stronger.The covering of the curved section may stretch or tear, which may cause water leakage.¿ please do not place or press the video connector or light guide connector on the insertion during transportation or reprocessing.Damage may occur.¿ please do not attach or remove the video connectors with the video system center power switched on.The image sensor may be destroyed if the video module is attached and detached while the video system center is turned on.¿ the remote switch of the endoscope cannot be removed from the operating section.Push, pull or twist with strong force may damage the switch or cause water leakage.¿ olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: 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: 17450203
• MDR Text Key: 320335331
• Report Number: 3002808148-2023-07913
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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
• Device Operator: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1