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

Model Number CYF-5

Device Problem Material Fragmentation (1261)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

The customer reported the oes cystonephrofiberscope was reprocessed and came out without the rubber on the distal end.The issue was found prior to beginning a case and the scope was not used in a procedure.There was no reported patient harm or impact due to this event.

Manufacturer Narrative

During device evaluation at olympus, it was found the bending section cover was torn and folded.The bending section cover was taped, but leaking.The battery holder was found to be corroded.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

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.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the event was caused by stress, handling, or other issues.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15668375
• MDR Text Key: 307078836
• Report Number: 9610595-2022-03289
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 09/30/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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