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 Date 04/03/2024

Event Type  malfunction  

Event Description

It was observed that during the device inspection, the videoscope distal end had foreign material near the objective lens.There were no reports of patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device evaluation found foreign material at the distal end near the objective lens, as well as a leak in the bending section cover.Based on the results of the investigation, it is likely that since the leakage failure occurred at the bending section cover, reprocessing could not be completed and foreign material remained at the distal end.However, 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 3 compatible reprocessing methods; 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.Olympus will continue to monitor the field performance of 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: 19188786
• MDR Text Key: 341356776
• Report Number: 3002808148-2024-03899
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/17/2024

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: 04/16/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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