MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VIDEOSCOPE "CYF-V2", UK VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Material Rupture (1546)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

The customer reported the bending section cover was ruptured off the distal end of the subject device.The reported issue was observed while reprocessing the subject device.There was no patient involvement.

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (bending section cover ruptured) was confirmed.In addition, service found there was a leakage from the bending section cover and it was not possible to seal the bending section cover.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.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.Based on the results of the investigation, the likely cause of the reported event is due to stress, handling, or other issues.However, the root cause of the reported event is unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "CYF-V2", UK VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• 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: 15670915
• MDR Text Key: 306896308
• Report Number: 9610595-2022-03320
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339431
• UDI-Public: 04953170339431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• 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