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  

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

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (h4) and to provide a correction to the initial (h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: 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.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.However, the root cause of the phenomenon could not be identified.The event can be prevented by following the instructions for use which state: "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: 18098780
• MDR Text Key: 327710200
• Report Number: 3002808148-2023-12514
• 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
• Report Date: 11/30/2023

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: 11/16/2023
• Supplement Dates FDA Received: 11/30/2023
• 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