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  

Event Description

It was observed during device inspection, that the charged coupled device (ccd) lens of the videoscope had foreign material and corrosion attached to the sides.There were no reports of patient involvement.

Manufacturer Narrative

Attempts to retrieve additional information from the customer are in progress.The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d5.Additional information added to field h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There were no device abnormalities to the objective lens where the foreign object was adhered.Therefore, the cause of the material remaining in the device could not be determined.The following is included in the instructions for use (ifu): chapter 4 reprocessing workflow for endoscopes and accessories.Chapter 5 reprocessing the endoscope (and related reprocessing accessories).-chapter 6 reprocessing the accessories.Chapter 7 reprocessing endoscopes and accessories using an aer/wd.The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization (cds) processes where no obvious deviations from instructions for use (ifu) were identified.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: 19152394
• MDR Text Key: 341664529
• Report Number: 3002808148-2024-03710
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: 04/10/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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