MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHR

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the distal end was observed to be separated from the units bending section.Distal end plastic cover observed to be separated from bending section.The identified parts needs to be replaced.Device was placed for repair.The reported issue was confirmed.The root cause of the failure likely attributed to users handling issue and or maintenance issue.

Event Description

It was reported that the user site facility requested and returned the device for a repair to change the units tube/bending section as a scheduled preventive maintenance.There was no patient involvement on this report, no user harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.Probable cause could be due to the weak adhesive strength of the apical region of the unit may have resulted in damage.Device was manufactured in february 27, 2012, eight years passed since manufacturing, it is possible that the failure occurred due to device age deterioration.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states : do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Olympus will continue to monitor complaints for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10653161
• MDR Text Key: 223662722
• Report Number: 8010047-2020-07431
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411298
• UDI-Public: 04953170411298
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1