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

A user facility reported to olympus that broken forceps were noted with the oes cystonephrofiberscope.During a standard service inspection of the customer returned device, forceps plug mouthpiece scrape was noted.This report is to capture the reportable malfunction found at inspection.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed.In addition, forceps plug mouthpiece came off and spots on the ig bundle were observed.Lastly, scratches were found on multiple device components.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.

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.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress, handling, or other factors.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This follow up report is being submitted to include additional information received from the customer.Olympus will continue to monitor complaints for this device.

Event Description

It was further reported that the issue occurred after procedure, before reprocessing.The same device was used to complete the operation.

• 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: 16046074
• MDR Text Key: 308353687
• Report Number: 3002808148-2022-05578
• Device Sequence Number: 1
• Product Code: FAJ
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

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: 12/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/25/2022
• Supplement Dates Manufacturer Received: 01/11/2023; 05/12/2023
• Supplement Dates FDA Received: 02/01/2023; 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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