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

Model Number CYF-VH

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the videoscope exhibited distal end, around the objective lens adhesive, had foreign material with corrosion.There was no patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation, associated h6 coding and an update to h3.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Three attempts were performed to obtain additional information, but no response was received from the customer.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and it was unknown if there were any deviations from the cleaning disinfection and sterilization (cds) steps provided in the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.The issue can be detected/prevented by following the instructions provided in: the reprocessing procedures of cyf-vh are described in ¿cysto-nephro videoscope olympus cyf-vh cyf-vhr reprocessing manual¿.It is possible that the indicated phenomenon can be prevented by this.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: 19143305
• MDR Text Key: 341386982
• Report Number: 3002808148-2024-03662
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: Other
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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