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

Model Number CYF-VHA

Device Problem Corroded (1131)

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

Event Type  malfunction  

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, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to an air leak from the forceps channel that led to corrosion at the angulation part.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

During inspection and testing of the returned device, service confirmed that switch #2 and switch #3 were not working, confirming the customer's reported issue.In addition, service found the forceps channel had a pinhole.Water ingress was observed in the main unit, the up/down plate, the light guide (lg) bundle, and the universal cord.The illumination lens and switch #4 were scratched.The insertion section was buckled and the coating was peeling.The curved tube was crushed.Dirt that was difficult to remove was found on the tip cover due to handling (insufficient cleaning).The rubber cover of the forceps stopper was peeled off.The universal cord was crushed.There was dirt found inside the forceps channel due to external factors.The video connector was deformed.Due to damage to the curved pipe, there was rattling at the connection between the curved pipe and the tip.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the switch of the subject device did not work.There was no report of patient or user injury due to the issue.The device was sent to an olympus service center for evaluation.During inspection and testing, service found the angle would lock due to corrosion of the angulation mechanism.This report is being submitted for the malfunction identified by service during evaluation of the device (angle locks).

• 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: 15166792
• MDR Text Key: 303424433
• Report Number: 3002808148-2022-00677
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1