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

Model Number CYF-V2

Device Problem Microbial Contamination of Device (2303)

Patient Problem Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

Additional details have been requested regarding the reported event.At this time, no additional information has been provided.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported to olympus that several patients had burning with urination after the cysto-nephro videoscope was used in diagnostic cystoscopy procedures.Results from urine cultures were not available at the time of this report.Aldahol was used to clean the scope.The customer performed extensive cleaning and reported seeing pink fluid come out of the scope and forceps irrigation plug.Related patient identifiers: (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to h10 of the previous submission.Please see correction below: a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.

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 evaluated by olympus and the reported issue was confirmed.The following non-reportable findings were also noted: leak failure due to internal cracks inside the biopsy channel.Bending section cover elongation and discoloration.Bending section cover adhesive lifting and scratched.All device switches malfunction.Scratches and dents on the insertion tube.Control body dry corrosion.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, poor leakage was identified in the biopsy channels which likely caused/contributed to the presence of the pink fluid.The event can be detected/prevented by following the instructions for use (ifu) in sections: chapter 6: compatible reprocessing methods and chemical agents.Chapter 7: cleaning, disinfection, and sterilization procedures.This supplemental report includes an update to h3 from the initial medwatch.Also, information has been added to h4.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: 18098717
• MDR Text Key: 327727342
• Report Number: 3002808148-2023-12512
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 11/21/2023
• Supplement Dates FDA Received: 11/21/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2009
• 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