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

Model Number CYF-5A

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the cystonephrofiberscope exhibited a broken channel tube.There were no reports of patient involvement.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the malfunction likely occurred due to excessive stress applied to the forceps plug during attachment, which led to the plug becoming loose and subsequently detaching.However, a definitive root cause could not be established.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: 19057057
• MDR Text Key: 340453889
• Report Number: 3002808148-2024-03251
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CYF-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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