MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5A

Device Problem Material Integrity Problem (2978)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the forceps port was loose.A review of the device history record found no deviations that could have caused or contributed to the loose forceps port.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the forceps port was loose because excessive external force was applied to the forceps hole when the tube was attached and detached from the forceps hole causing the adhesive between the forceps channel base and operation unit to be peeled off.Because the adhesive was peeled, the forceps port was loosened.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.The reported event (raised rubber cover) was confirmed during testing due to physical stress.In addition, angulation in the up direction did not meet standard due to wear of the angle wire, there was a scratch on the eyepiece due to handling, and the control unit was dirty due to water leakage.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

The customer reported that, during reprocessing, the rubber cover at the base of the instrument channel of the subject device was found to be raised.There was no harm or user injury reported due to the event.The subject device was sent to an olympus service center for evaluation.During inspection and testing, the forceps port was loose.This report is being submitted for the malfunction found during evaluation (loose port).

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 16412095
• MDR Text Key: 310244475
• Report Number: 3002808148-2023-01615
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2023

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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