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

Model Number CYF-VA2

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The customer's allegation was confirmed.The device evaluation found the tip was broken and bent when sterilized without a lid.Based on the results of the investigation, it is likely that the following led to the malfunction: as to reprocessing, a misuse of users could be assumed.We determined that the reported phenomenon might be prevented by following the instruction manual stated below.A definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): chapter 6 compatible reprocessing methods and chemical agents.6.5 ethylene oxide gas sterilization conditions.[caution].Attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported the videoscope tip was broken and bent when sterilized without a lid.There were no reports of patient harm.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19130422
• MDR Text Key: 341127786
• Report Number: 3002808148-2024-03599
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

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: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2023
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• 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