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

Model Number CYF-VH

Device Problem Mechanical Problem (1384)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.A full technical evaluation was completed in accordance with the original equipment manufacturer (oem) specification.The following defects/findings were identified during device evaluation: up angle/down angle inspection failed, noted to be inoperative.Up/down angle play inspection failed, noted to be inoperative.Bending angle return not to specification.Up/down angle control assembly inspection failed, mechanical resistance was observe.Stiff angle movement was noted furthermore, inspection found fluid contamination which caused corrosion and breakdown of nejilock and grease inside the control body.Another section of control body was inspected and found fluid ingress, rust and grease breakdown within the area.The internal section of angulation mechanism was inspected , found fluid ingress , rust and grease breakdown evident within the area.Device evaluation has confirmed the customer reported issue.Fluid ingress into the control body has caused corrosion which in turn has affected the operation of the angulation mechanism causing the mechanism to seize (¿lock¿) in place.Service repair noted that fluid invasion into the control body affects the angulation mechanism causing it to corrode and seize.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer sent the device for repair reported that the control handle has become locked, confirmed there was no clinical impact, issue occurred during preparation for use.The intended procedure was completed using a similar device.No harm was reported.No patient harm, no user injury reported.

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 cause of the event is likely due to a liquid intrusion into the device by mishandling, resulting in corrosion of the equipment.Therefore, the underlying cause was not specified.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 (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: 16580490
• MDR Text Key: 312289981
• Report Number: 3002808148-2023-02757
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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-VH
• Device Catalogue Number: N6006040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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