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

Model Number CYF-VH

Device Problem Connection Problem (2900)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus a channel malfunction; the lumen which connects the irrigation plug fell out of the cysto-nephro videoscope and returned the device to olympus for repair.The problem, as reported to olympus, occurred during reprocessing of the device.Upon inspection and testing of the returned device, it was found that biopsy port was missing.This report is submitted due to the finding that the biopsy port was missing, identified during in-house service of the device.As the problem was found during in-house service of the device, there was no patient involvement.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered that a leak test was unable to be performed as bx port was missing and insertion tube was dented.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the root cause could not be determined.Although it cannot be determined, it is likely stress or user handling caused the glue to peel.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15782585
• MDR Text Key: 307282641
• Report Number: 3002808148-2022-04078
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2022

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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