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

Model Number CYF-5

Device Problem Break (1069)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

A customer reported to olympus, the oes cystonephrofiberscope port was broken.The event occurred during reprocessing.There was no report of patient harm.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The scope biopsy port was broken and leaking.In addition, the image and eyepiece body were foggy.Due to biopsy port being missing, distal end insulation and insertion tube insulation could not be performed.The biopsy port was missing off control body.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.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 root cause of the broken port was caused by physical stress of the device.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: 16674396
• MDR Text Key: 312793806
• Report Number: 3002808148-2023-03286
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2006
• 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