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

Model Number CYF-5

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported, the cystonephrofiberscope had a torn bending rubber, with metal visible.The issue occurred during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Corrected fields: g2 - report source (foreign and other/japan were mistakenly selected).Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The customer reportable malfunction was not confirmed.Based on the results of the investigation, a definitive root cause for ¿bending rubber is ruptured, and metal is visible¿ could not be determined.The event can be detected/prevented by following the instructions for use which state: important information ¿ please read before use.Warnings and cautions do not strike the distal end of the insertion tube or allow it to strike other objects.The objective lens surface at the distal end is particularly fragile, and visual abnormalities may result.Do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18927923
• MDR Text Key: 339027926
• Report Number: 3002808148-2024-02544
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411144
• UDI-Public: 04953170411144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2008
• 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