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

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

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 Description

The customer reported to olympus that during reprocessing, the cysto-nephro videoscope was sterilized without the gas cap.There was no report of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.In addition, the following non-reportable malfunctions were found during the device evaluation the scope failed leak test, the bending section cover (a-rubber) leaking, missing color code on insertion tube, the light guide (lg) and video cable buckled.Lastly, the video connector has a cracked printed circuit board (pcb) and scratches on the master case (m-case).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 cause of the event is likely due to insufficient or inadequate reprocessing.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) sections: instructions visera cysto-nephro videoscope.Olympus cyf type v2.Olympus cyf type va2.Olympus cyf type v2r.Chapter 5 reprocessing: general policy.Chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA 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: 18268671
• MDR Text Key: 330673234
• Report Number: 3002808148-2023-13754
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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